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Critical RiskFDA Device

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Agency Publication Date: February 8, 2023
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Affected Products

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p

a) 870: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2200004, NT3DG2200009, NT3DG2200018, NT3DG2200002; b) 870 DR 3/8" NM GANTRY WITH NEW ROTOR - MEA: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2100018BH; c) 870 DR / Dismount: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100006; d) 870 DR / Dismount / 60HZ: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2000016BH; e) 870 DR 3/8" WSO: Catalog number H3906EM, UDI/DI Not Applicable, Serial Numbers: 870B64224, 870Z64148; f) 870 DR 3/8" NM Gantry: Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870Y64064, 870Y64040, 870A64172, 870Z64145, 870A64161, 870Z64111, 870Z64126, 870Y64081, 870A64210, 870X64003, 870A64180, 870Y64047, 870Y64044, 870Y64079, 870Y64050, 870Z64130, 870X64011, 870Y64095, 870Y64037, 870Y64074, 870Y64067, 870Y64051, 870A64162, 870X64024, 870A64163, 870A64165, 870X64002, 870Y64072, 870Z64107, 870Z64108, 870X64032, 870A64192, 870A64183, 870A64164, 870B64229, 870A64176, 870A64185, 870Z64137, 870Z64117, 870X64001, 870Y64055, 870Y64088, 870B64235, 870Y64078, 870Y64080, 870Z64125, 870Z64098, 870A64204, 870A64205, 870B64306, 870B64305, 870A64182, 870B64261, 870Y64069, 870Z64104, 870Y64042, 870Y64039, 870Y64086, 870Z64146, 870A64179, 870Y64085, 870A64168, 870Z64103, 870Y64094, 870Z64101, 870A64160, 870B64300, 870Y64046, 870B64302, 870A64199, 870Y64056, 870Z64121, 870A64174, 870X64004, 870X64012, 870X64007, 870Y64048, 870X64009, 870Z64124, 870X64026, 870Z64119, 870Z64122, 870Y64049, 870Y64089, 00000870Y64035, 870Z64134, 870Y64052, 870Y64076, 870Y64063, 870A64159, 870Z64133, 870B64286, 870B64247, 870B64244, 870A64184, 870B64240, 870B64264, 870B64287, 870A64196, 870A64187, 870B64307, 870A64208, 87EB77017, 870X64016, 870X64005, 870Z64136, 870Y64033, 870A64153, 870A64154, 870B64227, 870Y64091, 870B64231, 870B64292, 870Z64149, 87EA77011, 870X64022, 870Y64053, 870Z64114, 870Z64115, 87EZ77003, 87EB77016, 87EZ77004, 870B64233, 870Z64141, 87EB77014, 870A64175, 87EB77015, 870X64019, 870A64188, 870Y64059, 870Y64068, 870Y64071, 870Y64082, 870B64265, 870Z64102, 870X64020, 870Y64090, 870B64262, 870B64274, 870B64268, 870B64275, 870Z64128, 870B64270, 870B64271, 870B64272, 870B64273, 870B64266, 870B64280, 870B64267, 870Z64116, 870B64276, 870B64277, 870B64278, 870B64279, 870B64269, 870B64281, 870B64282, 870B64283, 870Z64142, 870Y64065, 870A64158, 870X64025, 87EZ77001, 870Z64120, 870Y64038, 870B64236, 870Y64077, 870A64202, 870A64207, 870B64251, 870B64221, 870A64197, 870X64010, 870Y64073, 870Y64036, 870Y64092, 870Y64087, 870X64027, 870X64029, 870Y64084, 870X64030, 870X64023, 870X64028, 87EA77010, 87EA77012, 870B64222, 870A64155, 870B64226, 870B64225, 87EB77018, 870B64297, 870B64299, 870B64293, 87EB77019, 870B64258, 870A64209, 87EZ77007, 870B64253, 870A64217, 870Z64127, 870B64285, 870Y64083, 870B64257, 870B64259, 870X64013, 870B64252, 870Z64105, 870Y64061, 870B64284, 870B64254, 870B64260, 870B64308, 870B64296, 870B64303, 870Z64110, 870Z64144, 870Y64075, 870A64171, 870A64215, 870A64212, 870Z64129, 870X64021, 870A64198, 870B64230, 870Z64113, 870Z64131, 870Z64132, 870Y64070, 870Z64140, 870B64263, 870B64294, 870A64190, 870Y64058, 870B64241, 870Z64135, 870Y64097, 870Z64099, 870Z64151, 870Y64057, 870A64157, 870B64242, 870B64243, 870B64250, 870Z64109, 870B64237, 870Z64106, 870A64173, 870X64008, 870A64152, 870B64218, 870B64234, 870B64238, 870B64239, 870A64200; g) 870 DR 3/8": Catalog number H3100AP, UDI/DI Not Applicable, Serial Numbers: 870Y64034; UDI/DI 010084068214083621870X6401511180900, Serial Numbers: 870X64015; h) 870 DR 3/8" CH: Catalog number H2402AG, UDI/DI To be provided, Serial Numbers: NT3DG1900005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1800002BH; i) 870 DR 5/8" NM GANTRY: Catalog number H3100Q, UDI/DI 010084068214083621870X6401811181000, Serial Numbers: 870X64017; UDI/DI 010084068214083621870Y6406611190700, Serial Numbers: 870Y64066; UDI/DI Not Applicable, Serial Numbers: 870Y64045, 870A64201, 00000870X64014, 870Y64041; j) 870 DR BJ / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG1900013BH; k) 870 DR CyberDefense 3/8" NM Gantry: Catalog number H3906FF, UDI/DI Not Applicable, Serial Numbers: 87CA83004, 87CA83001; , UDI/DI To be provided, Serial Numbers: 87CA83002, 87ZA83005; l) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870B64288, 00000870Z64139; m) 870 DR China: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100016BH; n) D670 NM GANTRY WITH NEW ROTOR: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870A64203, 87EA77013, 870B64255; o) D670 DR 3/8" 16 SL: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: DRGY56031, DRGY56025; UDI/DI Not Applicable, Serial Numbers: 00000DRGZ56044; Catalog number H3100BT, UDI/DI To be provided, Serial Numbers: 00000DRGX56017, 00000DRGZ56042; UDI/DI 010084068213935921DRGY5603011190700, Serial Numbers: DRGY56030; p) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG1900005BH; q) D670 DR 3/8": Catalog number H3100AK, UDI/DI Not Applicable, Serial Numbers: 00000589470GE4; r) D670 DR 3/8" 16SL: Catalog number 5791566, UDI/DI Not Applicable, Serial Numbers: DRGY56024; Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGY56026, DRGX56023, DRGX56009, DRGZ56047, DRGZ56049, DRGZ56045, DRGZ56051, DRGZ56056, DRGZ56046; s) D670 DR 3/8" 16SL NR: Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGZ56050; t) D670 DR 3/8" BJ: Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1800002BH, UDI/DI 01008406821393111119030021NT2RG1900001BH, Serial Numbers: NT2RG1900001BH; u) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG2200001BH; v) D670 DR NM Gantry 3/8": Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGX56002, DRGY56028, DRGX56005, DRGY56033, DRGX56004, DRGY56037, DRGX56003, DRGX56008, DRGX56007, DRGY56033, DRGZ56039, DRGX56011, DRGX56006, DRGX56021, DRGZ56054, DRGZ56040, DRGY56038, DRGY56032, DRGX56019, DRGZ56052, DRGX56012, DRGY56029, DRGY56027, DRGZ56048, DRGX56014, DRGZ56053, DRGZ56055, DRGY56034, DRGX56020, DRGX56016, DRGY56036, DRGX56022, DRGX56015, DRGZ56041; UDI/DI To be provided, Serial Numbers: DRGX56018, DRGA56057, DRGA56058; UDI/DI 010084068213935921DRGY5603511190900, Serial Numbers: DRGY56035; UDI/DI 010084068213935921DRGZ5604311200400, Serial Numbers: DRGZ56043; w) D670 DR NM Gantry 5/8": Catalog number H3100CM, UDI/DI Not Applicable, Serial Numbers: DRGX56010; x) D670 DR with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2RG1900003, NT2RG2000001BH; y) D670 ES NM Gantry 3/8": Catalog number H3100XF, UDI/DI Not Applicable, Serial Numbers: ESGY53002, ESGY53001, ESGY53003, ESGZ53005, ESGA53008, ESGB53011, ESGZ53004, ESGA53007, ESGZ53006, ESGA53010, ESGA53009; z) D670 ES NM/CT 3/8" O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8": Catalog number H3100BM, UDI/DI Not Applicable, Serial Numbers: ESPX54001, ESPY54002; bb) D670 GANTRY: Catalog number H3100BM , UDI/DI Not Applicable, Serial Numbers: ESPY54003; cc) D670 PRO NM Gantry 3/8": Catalog number H3100NC, UDI/DI UDI Not Required, Serial Numbers: 21128; dd) D670 PRO NM GANTRY 3/8": Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52045, PRGY52027, PRGA52061, PRGY52021, PRGY52023, PRGY52018, PRGZ52057, PRGY52013, PRGZ52048, PRGY52020, PRGZ52058, PRGX52008, PRGZ52046, PRGA52063, PRGA52068, PRGX52007, PRGZ52047, PRGZ52059, PRGA52066, PRGA52070, PRGY52039, PRGY52012, PRGZ52051, PRGX52004, PRGZ52055, PRGY52016, PRGX52009, PRGY52015, PRGZ52054, PRGY52031, PRGY52036, PRGY52024, PRGY52028, PRGY52025, PRGY52037, PRGY52032, PRGY52029, PRGZ52050, PRGX52005, PRGA52064, PRGY52030, PRGZ52056, PRGA52069, PRGX52002, PRGX52006, PRGX52003, PRGA52060; , UDI/DI UDI_Not_Required_2, Serial Numbers: PRGY52035; , UDI/DI To be provided, Serial Numbers: PRGA52077, PRGA52072, PRGA52073, PRGA52075, PRGB52083, PRGA52076, PRGA52079, PRGB52080, PRGB52081, PRGB52082, PRGA52071, PRGA52074, PRGB52084, PRGA52078; UDI/DI 010084068213937321PRGX5200111180700, Serial Numbers: PRGX52001; UDI/DI 010084068213937321PRGX5201011181200, Serial Numbers: PRGX52010; UDI/DI 010084068213937321PRGY5201111190100, Serial Numbers: PRGY52011; UDI/DI 010084068213937321PRGY5201711190300, Serial Numbers: PRGY52017; ee) DISC NM/CT670 DR 3/8": Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1900002BH; UDI/DI To be provided, Serial Numbers: T2RG1900004BH; ff) DISC NM/CT870 DR 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EA77009, 870A64177, 870A64156, 870Y64043, 870Z64112, 870Z64150; UDI/DI UDI Not Required, Serial Numbers: 870Y64096; UDI/DI To be provided, Serial Numbers: 870B64304, 00000870Z64147, 870Y64093, 870B64245; gg) DISC NM/CT870 DR 5/8": Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870X64018; hh) DISCOVERY 670 (TANDEM): Catalog number H3100XB , UDI/DI To be provided , Serial Numbers: PRGZ52040; ii) DISCOVERY NM 670: Catalog number 5474053, UDI/DI To be provided, Serial Numbers: 27053; kk) DISCOVERY NM/CT 670 3/8" PRO: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52044, PRGA52065, PRGY52033, PRGZ52041, PRGZ52043, PRGZ52052, PRGY52026, PRGY52022, PRGY52014, PRGA52067, PRGY52034, PRGA52062; UDI/DI UDI_Not_Required_2, Serial Numbers: PRGZ52049, PRGZ52042; UDI/DI To be provided, Serial Numbers: PRGY52019; ll) DISCOVERY NM/CT 670 3/8" PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 00000870Y64060; nn) NM/CT 870 DR: Catalog number H3100AS , UDI/DI To be provided, Serial Numbers: 87EZ77008; oo) NM/CT 870 DR 3/8" CYBER DEFENCE: Catalog number H3906FF, UDI/DI To be provided, Serial Numbers: 87ZB83006, 87CA83003; pp) NM/CT 870 DR 3/8" WSO: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870A64189, 870A64216, 870B64228, 870B64220, 870B64223, 870A64181, 870A64211, 870A64213, 870B64249; Catalog number 5376204-70-60, UDI/DI 010084068214083621870A6421411211100, Serial Numbers: 870A64214; UDI/DI 010084068214083621870A6419511210900, Serial Numbers: 870A64195; UDI/DI 010084068214083621870A6419411210800, Serial Numbers: 870A64194; UDI/DI 010084068214083621870B6425611220500, Serial Numbers: 870B64256; UDI/DI 010084068214083621870A6419311210800, Serial Numbers: 870A64193; UDI/DI 010084068214083621870B6423211220200, Serial Numbers: 870B64232; UDI/DI 010084068214083621870B6424611220300, Serial Numbers: 870B64246; UDI/DI 010084068214083621870B6424811220300, Serial Numbers: 870B64248; UDI/DI 010084068214083621870A6419111210800, Serial Numbers: 870A64191; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870B64295; qq)NM/CT 870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900012BH, NT3DG2000001BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200013BH; Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870X64031, 87EZ77006, 87EZ77005, 870Z64143, 870Y64062, 870Z64123, 870Z64118, 870A64169, 870A64166; : Catalog number To be provided, UDI/DI 010084068214083621870B6429111221100, Serial Numbers: 870B64291; Catalog number To be provided, UDI/DI 010084068214083621870B6430111221100, Serial Numbers: 870B64301; rr) NM/CT 870 DR O540 3/8" BJ: Catalog number 5376204-70-60-1, UDI/DI 01008406821421201121050621NT3DG2100005BH, Serial Numbers: NT3DG2100005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1900014BH, NT3DG1900015BH, NT3DG2100010BH, NT3DG2100007BH, NT3DG2200005BH, NT3DG1900002BH, NT3DG2100011BH, NT3DG2200003BH, NT3DG2200014BH, NT3DG2000012BH, NT3DG1900001BH, NT3DG1800001BH, NT3DG2100003BH, NT3DG2200007BH, NT3DG2100001BH, NT3DG2100012BH, NT3DG2100008BH; UDI/DI To be provided, Serial Numbers: NT3DG1900009BH, NT3DG2200004BH, NT3DG2000013BH, NT3DG1900006BH, NT3DG2100002BH, NT3DG1900004BH, NT3DG1900011BH, NT3DG2100013BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200019BH, NT3DG2000003BH, NT3DG2000005BH, NT3DG2000006BH; : Catalog number To be provided, UDI/DI Not Applicable , Serial Numbers: NT3DG2000004BH, NT3DG2200011BH, NT3DG2200017BH, NT3DG2000014BH; ss) NM/CT 870 DR O540 5/8": Catalog number H3100Q, UDI/DI Not Applicable, Serial Numbers: 870A64170; Catalog number 5791566, UDI/DI Not Applicable , Serial Numbers: 870Z64138, 870B64219; tt) NM/CT 870 ES 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EZ77002; uu) NM/CT 870DR China for China: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200010BH; NT3DG2200015BH, NT3DG2100015BH, NT3DG2200006BH, NT3DG2200001BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200016BH, NT3DG2200012BH; vv) NM/CT 870 DR 3/8" O540: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2000008BH, NT3DG2000010BH, NT3DG2000011BH, NT3DG2100009BH, NT3DG2100014BH, NT3DG2100004BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200008BH ww) NM/CT D870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900010BH, NT3DG1900003BH, NT3DG2000015BH; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2000002BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870A64186; xx) TANDEM DISCOVERY 670 INT: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGY52038.

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WIT

a) 830: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200003, NT3AG2000015BH, NT3AG2100015BH, NT3AG2200006BH; b) 830 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial numbers: NT3AG2100016BH; c) 830 /: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100009BH; d) 830 / 5842894-20: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200013; e) 830 / Dismount / 50HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2000017BH; f) 830 / Dismount / 60HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100001; g) 830 3/8 inch Detector: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60105; h) 830 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900009BH; Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG1900015BH; i) 830 BJ / 5144407: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900008BH; j) 830 BJ / Dismount: Catalog number 5376204-32-1, UDI/DI To be provided, Serial Numbers: NT3AG1900016BH; k) 830 ES DEM: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88002, 830Z60256; l) 830 NM Cyber Defense Configuration Gantry 3/8 inch: Catalog number H3910AG, UDI/DI Not Applicable, Serial Numbers: 830Z60185, 830Z60224, 830Z60225; m) 830 NM Gantry 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60050, 830Z60199, 830A60284, 830A60290, 830X60001, 830X60004, 830Y60056, 830Y60069, 830Z60158, 830Z60182, 83EA88010, 830Z60183, 830A60282, 830Z60192, 830A60271, 830Y60122, 830A60298, 830A60289, 830Y60048, 830Y60036, 830Z60239, 830A60294, 830Y60046, 830X60012, 830Y60054, 830Z60269, 830X60018, 830A60283, 830Y60089, 830Y60096, 830Z60165, 830Z60169, 830Y60051, 830Z60244, 830A60288, 830X60026, 830Y60030, 830Z60197, 830Z60227, 830A60277, 830A60334, 830Y60079, 830Y60131, 830Y60141, 83EA88008, 830Z60238, 830Z60207, 830Z60248, 830Y60137, 830Z60149, 830Z60175, 830Y60076, 830Y60092, 830Y60090, 830A60301, 830A60279, 830Z60178, 830Z60153, 830Y60132, 830X60011, 830X60016, 830Y60102, 830Z60253, 830Z60264, 830Y60049, 830Z60265, 830Z60254, 830Y60081, 830Z60263, 830Z60200, 830A60308, 830A60300, 830Z60171, 830Y60057, 830Y60029, 830Y60106, 830Y60059, 830Z60177, 830A60291, 830Z60267, 830Z60174, 830Z60245, 830Y60074, 830Z60167, 830Y60071, 830Z60246, 830Z60223, 830Z60201, 830Y60045, 830X60019, 83EZ88001, 830Y60124, 830A60306, 830A60297, 830Z60213, 830Y60111, 830Y60127, 830Y60094, 830Z60258, 830Y60058, 830Z60218, 830Y60138, 830A60280, 830A60274, 830Z60211, 830Y60101, 830Z60210, 830Z60260, 830Z60234, 830Y60118, 830X60027, 830Z60228, 830Z60168, 830Z60214, 830Y60044, 830Y60053, 830Z60173, 830Z60195, 830Y60123, 830Y60117, 830Y60129, 830Z60148, 830X60023, 830X60006, 830Y60104, 830X60015, 830Y60121, 830A60281, 830Y60133, 830Y60098, 830Z60268, 830Z60194, 830Z60198, 830X60014, 830Y60040, 830X60003, 830Z60159, 830Z60237, 830Y60060, 830A60278, 83EA88006, 830Z60222, 830Z60250, 830Z60181, 830Y60134, 830Z60152, 830Z60202, 830Z60220, 830Z60230, 830Y60062, 830Y60097, 830Z60176, 830Z60196, 830Y60125, 830X60025, 830A60293, 830A60307, 830Z60249, 830Z60180, 830Y60064, 830Y60078, 830Y60115, 830Y60114, 830Y60043, 830Y60108, 830A60275, 830Y60130, 830Z60229, 830A60292, 830Z60163, 830Y60128, 830X60021, 830Z60266, 830Y60100, 830A60304, 830Y60099, 830Y60034, 830Y60087, 830X60028, 830Y60084, 830Y60055, 830Y60136, 830Z60188, 830Z60206, 830Z60151, 830X60017, 830Y60140, 83EA88009, 830Z60154, 830Y60112, 830A60276, 830Y60082, 830Y60093, 830A60305, 830Z60232, 830Y60066, 830Z60191, 830Z60236, 830A60285, 830Z60235, 830Z60157, 830Y60126, 830Y60142, 830Y60035, 83EA88007, 830A60286, 830Y60107, 830Y60080, 830X60002, 830Z60270, 830Y60067, 830Z60193, 830Z60172, 830X60022, 830Y60095, 830Y60119, 830Y60042, 830Z60156, 830X60024, 830B60457, 830Y60047, 830Z60205, 830X60013, 830Y60073, 830Y60032, 830A60310, 830Z60219, NT3AG1900017BH, 830Z60257, 830Z60247, 830Z60240, 830Z60203, 830Y60085, 830Y60077, 830Z60255, 830A60311, 830Y60033, 830X60020, 830A60287, 830Y60038, 83EZ88004, 83EZ88005, 830X60010, 830Z60252, 830Z60166, 830Y60061, 830Y60091, 830Z60184, 830A60309, 830Z60217, 830Z60155, 830X60005, 830X60008, 830X60009, 830Y60052, 830Y60063, 830Y60143, 830Y60144, 830Y60146, 830Z60231, 830Z60187, 830A60296, 830Y60041, 830Y60088, 830Z60226, 830Z60262, 830X60007, 830Z60259, 830Z60212, 830Y60065, 830Y60135, 830Z60204, 830Y60072, 830Z60160; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60113; , UDI/DI UDI_Not_Required_6, Serial Numbers: 830A60299; UDI/DI 010084068214082921830A6032811210700, Serial Numbers: 830A60328; UDI/DI 010084068214082921830Z6015011200100, Serial Numbers: 830Z60150; UDI/DI 010084068214082921830A6027211210100, Serial Numbers: 830A60272; UDI/DI 010084068214082921830B6042411220500, Serial Numbers: 830B60424; UDI/DI 010084068214082921830Z6019011200400, Serial Numbers: 830Z60190; UDI/DI 010084068214082921830A6027311210100, Serial Numbers: 830A60273; UDI/DI 010084068214082921830Z6018911200400, Serial Numbers: 830Z60189; UDI/DI 010084068214082921830Y6007511190600, Serial Numbers: 830Y60075; UDI/DI (01)00840682140829(21)830B60400(11)220200, Serial Numbers: 830B60400; UDI/DI 010084068214082921830Z6017011200200, Serial Numbers: 830Z60170; UDI/DI (01)00840682140829(21)830A60346(11)211100, Serial Numbers: 830A60346; UDI/DI 010084068214082921830Y6010311190900, Serial Numbers: 830Y60103; UDI/DI 010084068214082921830Y6014511191200, Serial Numbers: 830Y60145; UDI/DI 010084068214082921830A6030311210500, Serial Numbers: 830A60303; UDI/DI (01)00840682140829(21)830A60345(11)211000, Serial Numbers: 830A60345; UDI/DI 010084068214082921830A6029511210300, Serial Numbers: 830A60295; UDI/DI 010084068214082921830Z6023311200900, Serial Numbers: 830Z60233; UDI/DI 010084068214082921830Z6020911200600, Serial Numbers: 830Z60209; UDI/DI (01)00840682140829(21)830B60386(11)220100, Serial Numbers: 830B60386; UDI/DI (01)00840682140829(21)830B60434(11)220600, Serial Numbers: 830B60434; UDI/DI 010084068214082921830Y6010911191000, Serial Numbers: 830Y60109; UDI/DI 010084068214082921830Z6016211200200, Serial Numbers: 830Z60162; UDI/DI 010084068214082921830Z6017911200300, Serial Numbers: 830Z60179; UDI/DI 010084068214082921830Z6018611200300, Serial Numbers: 830Z60186; UDI/DI 010084068214082921830B6042711220500, Serial Numbers: 830B60427; UDI/DI 010084068214082921830A6037811211200, Serial Numbers: 830A60378; , UDI/DI To be provided, Serial Numbers: 830B60383, 830A60337, 830A60373, 830A60368, 830B60387, 830B60458, 830B60459, 830B60460, 830B60462, 830B60464, 830B60465, 830B60466, 830B60421, 830B60430, 830B60443, 830B60456, 830B60473, 830B60384, 83EB88026, 83EA88017, 830A60317, 830B60401, 830B60432, 830B60422, 830B60467, 830B60471, 830B60398, 830A60364, 83EB88027, 83EB88028, 830A60326, 830B60411, 830B60469, 830B60472, 830B60389, 830A60333, 830A60347, 830A60348, 830B60447, 830A60313, 830A60375, 830A60374, 830B60412, 830A60339, 830B60461, 830B60463, 830B60470, 830A60365, 830B60446, 830B60397, 83EB88034, 83EB88025, 83EA88011, 830B60431, 830B60428, 830B60416, 830B60441, 830A60363; n) 830 NM Gantry 5/8 inch: Catalog number H3910AD, UDI/DI To be provided, Serial Numbers: 830B60468, 830B60379; o) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2000009BH; p) B615 to D630 UPG: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT2UG2100001; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2UG2100002; q) D630 NM GANTRY: Catalog number H3100JY, UDI/DI 01008406821392742163GX5002611180700, Serial Numbers: 63GX50026; Catalog number H3100JY, UDI/DI Not Applicable, Serial Numbers: 0000063GX50023; r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA: Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT2PG2000001BH; s) D630 NM Gantry 3/8 inch: Catalog number H3101RH, UDI/DI Not Applicable, Serial Numbers: 63GY50074, 63GX50024, 63GZ50134, 63GY50110, 63GY50119, 63GY50067, 63GY50123, 63GX50001, 63GX50037, 63GX50060, 63GY50089, 63GY50087, 63GY50098, 63GY50097, 63GX50034, 63GZ50152, 63GY50094, 63GY50128, 63GY50131, 63GX50014, 63GY50079, 63GY50130, 63GY50101, 63GZ50147, 63GZ50136, 63GX50019, 63GZ50150, 63GZ50141, 63GY50078, 63GX50022, 63GX50021, 63GX50031, 63GX50018, 63GY50082, 63GX50009, 63GY50080, 63GY50118, 63GZ50133, 63GY50077, 63GX50043, 63GY50116, 63GX50020, 63GX50054, 63GX50008, 63GX50035, 63GX50050, 63GX50061, 63GX50062, 63GY50085, 63GZ50151, 63GY50125, 63GY50102, 63GX50032, 63GX50055, 63GY50090, 63GX50013, 63GX50047, 63GX50002, 63GX50025, 63GX50033, 63GX50038, 63GY50115, 63GX50044, 63GY50129, 63GY50120, 63GY50068, 63GX50063, 63GY50104, 63GY50069, 63GX50016, 63GY50075, 63GX50017, 63GX50005, 63GY50084, 63GX50029, 63GZ50135, 63GX50012, 63GY50127, 63GY50124, 63GX50046, 63GZ50148, 63GX50039, 63GX50049, 63GY50083, 63GX50011, 63GX50030, 63GY50108, 63GY50103, 63GY50113, 63GY50114, 63GZ50146, 63GX50057, 63GZ50145, 63GA50153, 63GZ50149, 63GY50100, 63GZ50142, 63GX50045, 63GA50155, 63GA50154, 63GY50111, 63GY50112, 0000063GX50048, 63GX50040, 63GX50003, 63GX50065, 63GZ50137, 63GY50107, 63GZ50138, 63GX50042, 63GY50088, 63GY50126, 63GX50053, 63GX50004, 63GY50086, 63GZ50132, 63GX50056, 63GX50066, 63GX50059;UDI/DI 01008406821392742163GY5007611190200, Serial Numbers: 63GY50076; UDI/DI 01008406821392742163GX5005111181000, Serial Numbers: 63GX50051; UDI/DI 01008406821392742163GX5005211181000, Serial Numbers: 63GX50052; UDI/DI 01008406821392742163GY5007011190100, Serial Numbers: 63GY50070; UDI/DI 01008406821392742163GY5009511190400, Serial Numbers: 63GY50095; UDI/DI 01008406821392742163GY5012111191100, Serial Numbers: 63GY50121; UDI/DI 01008406821392742163GX5002711180700, Serial Numbers: 63GX50027; UDI/DI 01008406821392742163GX5003611180700, Serial Numbers: 0000063GX50036; UDI/DI 01008406821392742163GY5009611190400, Serial Numbers: 63GY50096; UDI/DI 01008406821392742163GX5000711180500, Serial Numbers: 63GX50007; UDI/DI 01008406821392742163GX5000611180500, Serial Numbers: 63GX50006; UDI/DI 01008406821392742163GX5001011180600, Serial Numbers: 63GX50010; UDI/DI 01008406821392742163GX5001511180600, Serial Numbers: 63GX50015; UDI/DI 01008406821392742163GY5011711190900, Serial Numbers: 63GY50117; UDI/DI 01008406821392742163GY5007111190100, Serial Numbers: 63GY50071; UDI/DI 01008406821392742163GY5007211190100, Serial Numbers: 63GY50072; UDI/DI (01)00840682139274(21)63GY50106(11)190700, Serial Numbers: 63GY50106; UDI/DI 01008406821392742163GY5007311190100, Serial Numbers: 63GY50073; UDI/DI To be provided, Serial Numbers: 63GX50041, 63GY50105, 63GA50161, 63GB50165, 63GA50162, 63GA50157, 63GA50159, 63GA50160, 63GA50156, 63GA50163, 63GB50166; t) D630 NM GANTRY FINAL ASSEMBLY, : Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830B60423, 830B60429; u) D630 with new rotor: Catalog number H2405AC, UDI/DI To be provided, Serial Numbers: NT2PG1900006, NT2PG1900005; v) D630 with new rotor/ 5144407 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2PG1900007BH; w) D630 with new rotor/ Dismount: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1800001BH; x) DISCOVERY D630 X3/8 inch: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900009BH, NT2PG1900008BH; y) DISCOVERY D630X 3/8 inch: Catalog number 5791570, UDI/DI Not Applicable, Serial Numbers: 0000063GZ50139; z) DISCOVERY D630X3/8 inch: Catalog number H3101RH, UDI/DI 01008406821392742163GY5009111190400, Serial Numbers: 63GY50091; UDI/DI Not Applicable, Serial Numbers: 63GY50093, 63GY50099, 63GZ50144, 63GZ50140, 63GY50122, 63GY50092, 63GB50164, 63GX50064, 63GX50028, 63GX50058, 63GY50081, 63GY50109, 63GZ50143; aa) DISCOVERY D630x3/8 inch BHW: Catalog number H2405AC, UDI/DI 01008406821393281119060021NT2PG1900010BH, Serial Numbers: NT2PG1900010BH; bb) DISCOVERY D630X3/8 inch BJG: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900004BH, NT2PG1900001BH, NT2PG1900002BH, NT2PG1900012BH; cc) DISCOVERY D630X3/8 inch MEA: Catalog number 5376204-31-1, UDI/DI 01008406821393281119100021NT2PG1900011BH, Serial Numbers: NT2PG1900011BH; dd) DISCOVERY NM 830 3/8 inch: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; UDI/DI To be provided, Serial Numbers: NT3AG2100004BH, NT3AG2200007BH; UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; ee) DISCOVERY NM 830 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60110, 830Z60164; ff) NM 830 3/8 inch: Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830A60336, 830Y60031; Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT3AG2000005BH; Catalog number 5376204-32, UDI/DI 010084068214082921830A6035511211100, Serial Numbers: 830A60355; UDI/DI 010084068214082921830A6032511210700, Serial Numbers: 830A60325; UDI/DI 010084068214082921830A6037111211200, Serial Numbers: 830A60371; UDI/DI 010084068214082921830B6040911220300, Serial Numbers: 830B60409; UDI/DI 010084068214082921830B6043911220700, Serial Numbers: 830B60439; UDI/DI 010084068214082921830B6041411220400, Serial Numbers: 830B60414; UDI/DI 010084068214082921830A6032411210700, Serial Numbers: 830A60324; UDI/DI 010084068214082921830B6041511220400, Serial Numbers: 830B60415; UDI/DI 010084068214082921830B6043311220600, Serial Numbers: 830B60433; UDI/DI 010084068214082921830A6032911210800, Serial Numbers: 830A60329; UDI/DI 010084068214082921830B6044211220700, Serial Numbers: 830B60442; UDI/DI 01008406821408292183EB8803111220700, Serial Numbers: 83EB88031; UDI/DI 010084068214082921830B6044411220700, Serial Numbers: 830B60444; UDI/DI 010084068214082921830A6034411211000, Serial Numbers: 830A60344; UDI/DI 010084068214082921830B6040411220300, Serial Numbers: 830B60404; UDI/DI 010084068214082921830A6033211210800, Serial Numbers: 830A60332; UDI/DI 010084068214082921830A6032311210700, Serial Numbers: 830A60323; UDI/DI 010084068214082921830B6040211220200, Serial Numbers: 830B60402; UDI/DI 010084068214082921830A6035211211100, Serial Numbers: 830A60352; UDI/DI 010084068214082921830B6044811221000, Serial Numbers: 830B60448; UDI/DI 010084068214082921830A6031511210600, Serial Numbers: 830A60315; UDI/DI 010084068214082921830A6031811210600, Serial Numbers: 830A60318; UDI/DI 010084068214082921830B6042511220500, Serial Numbers: 830B60425; UDI/DI 010084068214082921830A6031911210600, Serial Numbers: 830A60319; UDI/DI 010084068214082921830A6036611211200, Serial Numbers: 830A60366; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60147, 830B60455, 830Z60261, 830Z60221, 830Z60215, 830Y60070, 830Y60083, 830Y60037, 830Z60161, 830Y60039, 830A60302, 830Z60216, 830Z60242, 830Z60241, 830Z60251, 830Y60086, 830Z60243, 830Z60208; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60116; UDI/DI To be provided, Serial Numbers: 830A60356, 830B60449, 830A60350, 83EB88032, 830A60322, 830B60445, 830B60435, 830A60358, 830B60408, 830A60349, 830B60453, 830A60357, 830A60335, 830B60410, 830B60395, 830A60354, 830B60385, 830A60331, 830B60396, 830A60360, 830B60381, 830B60406, 830B60403, 830A60320, 830A60321, 830B60426, 830B60388, 830A60369, 830B60399, 830B60419, 830A60377, 830A60316, 830B60382, 830B60452, 830A60370, 830A60376, 830B60413, 830A60314, 830A60367, 830B60394, 830B60436, 830A60342, 830A60362, 830B60440, 830B60407, 830A60312, 830B60380, 830B60418, 830A60353, 830A60330, 830B60390, 830A60372, 830A60359, 830A60341, 830A60338, 830A60327, 830B60405, 830A60361, 830B60454, 830A60340, 830A60351; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 830B60437, 830B60393, 830B60420, 830B60438, 830A60343; gg) NM 830 3/8 inch BJ: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200001BH, NT3AG2100007BH, NT3AG2100003BH, NT3AG2000008BH, NT3AG2000002BH, NT3AG2200010BH, NT3AG1900002BH , NT3AG2200009BH, NT3AG1900014BH, NT3AG1900012BH, NT3AG2000006BH, NT3AG2100008BH, NT3AG2000013BH, NT3AG2100010BH, NT3AG2200005BH, NT3AG1900011BH, NT3AG2000016BH, NT3AG2100002BH, NT3AG2200011BH, NT3AG2100011BH, NT3AG1900018BH, NT3AG2000001BH, NT3AG1900003BH, NT3AG1900001BH, NT3AG1800001BH, NT3AG2100014BH, NT3AG1900010BH, NT3AG2000003BH, NT3AG2000012BH, NT3AG1900006BH, NT3AG2100005BH, NT3AG2000011BH, NT3AG2200008BH, NT3AG1800002BH, NT3AG2000010BH; UDI/DI To be provided, Serial Numbers: NT3AG2200014BH, NT3AG1900013BH, NT3AG2200002BH, NT3AG2100012BH, NT3AG2100013BH; Catalog number H2406AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1800003BH, NT3AG1900004BH, NT3AG2200016, NT3AG2200015BH; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88003; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200004BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3AG1900005BH, NT3AG2000004BH; hh) NM 830 ES: Catalog number 5376204-32, UDI/DI 01008406821408292183EA8801811211000, Serial Numbers: 83EA88018; UDI/DI 01008406821408292183EA8801411210800, Serial Numbers: 83EA88014; UDI/DI 01008406821408292183EB8801911220100, Serial Numbers: 83EB88019; UDI/DI 01008406821408292183EB8802311220200, Serial Numbers: 83EB88023; UDI/DI 01008406821408292183EB8803011220500, Serial Numbers: 83EB88030; UDI/DI 01008406821408292183EA8801211210600, Serial Numbers: 83EA88012; UDI/DI 01008406821408292183EA8801511210900, Serial Numbers: 83EA88015; UDI/DI 01008406821408292183EA8801311210800, Serial Numbers: 83EA88013; UDI/DI 01008406821408292183EB8802411220200, Serial Numbers: 83EB88024; Catalog number H3910AC, UDI/DI To be provided, Serial Numbers: 83EB88029, 83EB88022, 83EA88016; UDI/DI Not Applicable, Serial Numbers: 83EB88021; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 83EB88020; ii) NM DISCOVERY D630 3/8 inch: Catalog number 5474054, UDI/DI To be provided, Serial Numbers: 22404; jj) NUC GOLDSEAL D630X3/8 inch: Catalog number S9630NU, UDI/DI Not Applicable, Serial Numbers: NT2QG1900003BH.

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

a) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH; b) BRIVO 615 3/8 inch: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG2000002BH; c) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH; d) B615 with new rotor: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG1900002BH; e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH; f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP, UDI/DI To be provided, Serial Numbers: 00000168527HL0; g) B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH;

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64GY51004, 0000064GY51011, 64GY51005; b) DISCOVERY O640X 3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GY51021; c) NM OPTIMA O640X3/8 inch: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 26043; d) O640 NM Gantry 3/8 inch: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51022; , UDI/DI Not Applicable, Serial Numbers: 64GY51024, 64GY51007, 64GY51019, 64GY51018, 64GY51016, 64GX51001, 64GY51006, 64GY51013, 64GZ51026, 64GY51025, 64GY51012, 64GY51023, 64GY51014, 64GZ51027; UDI/DI To be provided, Serial Numbers: 64GY51008, 64GY51009, 64GY51020, 64GZ51028, 64GZ51030, 64GY51015, 64GY51011; e) O640 NM GANTRY FINAL ASSY: Catalog number H3100JZ, UDI/DI To be provided, Serial Numbers: ONMX26515; f) OPTIMA O640X3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GZ51029, 64GZ51031; Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51017; UDI/DI To be provided, Serial Numbers: 64GY51010.

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300, Serial Numbers: 87CZ63042; UDI/DI 01008406821408432187CA6305311210100, Serial Numbers: 87CA63053; UDI/DI 01008406821408432187CX6301111181000, Serial Numbers: 87CX63011; UDI/DI 01008406821408432187CY6302011190300, Serial Numbers: 87CY63020; UDI/DI 01008406821408432187CY6303511191100, Serial Numbers: 87CY63035; UDI/DI 01008406821408432187CZ6304011200100, Serial Numbers: 87CZ63040; UDI/DI 01008406821408432187CX6300411180700, Serial Numbers: 87CX63004; UDI/DI 01008406821408432187CX6300911180900, Serial Numbers: 87CX63009; UDI/DI 01008406821408432187CB6307211220700, Serial Numbers: 87CB63072; UDI/DI 01008406821408432187CA6306111211100, Serial Numbers: 87CA63061; UDI/DI 01008406821408432187CY6303211191000, Serial Numbers: 87CY63032; UDI/DI To be provided, Serial Numbers: 87CB63075, 87CA63058, 87CB63070, 87CB63069, 87CB63071, 87CB63077, 87CA63063, 87CB63064, 87CB63078, 87CA63062, 87CB63067, 87CA63057, 87CA63060, 87CB63065, 87CB63068, 87CB63074; UDI/DI Not Applicable, Serial Numbers: 87CY63019, 87CA63054, 87CZ63043, 87CA63055, 87CY63028, 87CY63037, 87CZ63044, 87CZ63045, 87CZ63048, 87CZ63041, 87CY63024, 87CY63017, 87CX63007, 87CX63008, 87CX63006, 87CX63014, 87CY63022, 87CX63015, 87CY63025, 87CX63010, 87CZ63052, 87CY63027, 87CY63026, 87CY63030, 87CZ63046, 87CX63013, 87CY63036, 87CZ63047, 87CY63033, 87CY63016, 87CX63005, 87CZ63039, 87CX63002, 87CX63012, 87CX63001, 87CY63023, 87CY63018; b) D670 CZT Gantry 7.25mm: Catalog number H3906DD, UDI/DI Not Applicable, Serial Numbers: CZGA55003, CZGA55004, CZGY55001; , UDI/DI To be provided, Serial Numbers: CZGB55006, CZGA55005, CZGB55007; c) DISCOV NM/CT 870 CZT: Catalog number H3906CW, UDI/DI 01008406821408432187CY6303811191200, Serial Numbers: 87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable, Serial Numbers: CZGZ55002; e) NM/CT 870 CZT CYBER DEFENCE: Catalog number H3906FK, UDI/DI To be provided, Serial Numbers: 87DB82001; f) NM/CT 870 CZT O540: Catalog number H3906CW , UDI/DI Not Applicable, Serial Numbers: 87CY63021, 87CZ63050, 87CZ63049, 87CZ63051, 87CY63034; g) NM/CT 870 CZT WSO: Catalog number 5376204-70-20, UDI/DI 01008406821408432187CA6305911210800, Serial Numbers: 87CA63059; UDI/DI 01008406821408432187CB6307611221000, Serial Numbers: 87CB63076; UDI/DI 01008406821408432187CB6307311220800, Serial Numbers: 87CB63073; : Catalog number H3906CW, UDI/DI To be provided, Serial Numbers: 87CB63066; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 87CA63056; h) NM/CT 870 CZT: Catalog number H3906CW, UDI/DI Not Applicable, Serial Numbers: 87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700, Serial Numbers: 87CX63003; UDI/DI 01008406821408432187CY6302911190800, Serial Numbers: 87CY63029

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE,

a) 850: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2200006BH; b) 850 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2100003BH; c) 850 3/8 inch NM Gantry: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EY67037, 850Z61033, 85EY67039, 85EY67048, 850Y61018, 850Y61009, 85EY67035, 85EX67001, 85EX67020, 85EY67045, 85EX67023, 85EY67032, 85EY67046, 850A61063, 850Z61047, 85EY67047, 850Z61053, 850Y61006, 850Y61010, 850X61005, 850Y61021, 85EZ67062, 85EX67019, 85EX67021, 85EA67063, 850A61069, 85EX67008, 85EY67040, 850Z61051, 850Z61038, 850A61075, 850Y61025, 850Z61030, 85EY67015, 85EX67017, 85EY67043, 850Z61042, 850Z61061, 85EY67026, 850A61065, 85EX67012, 850Y61023, 85EY67041, 850A61062, 850A61076, 850Y61012, 850A61064, 85EZ67058, 85EX67006, 850Z61043, 850Z61055, 85EY67042, 85EZ67055, 85EY67036, 85EX67024, 85EY67038, 85EX67022, 85EY67025, 85EZ67060, 850Z61058, 850Z61044, 850Z61045, 850Y61020, 850Z61032, 85EZ67056, 85EA67065, 85EY67028, 850Z61041, 85EX67002, 85EX67009, 850A61072, 850Z61036, 850A61068, 850A61071, 850Z61060, 850Z61034, 850Z61039, 850Z61035, 850Z61040, 85EY67031, 850Z61056, 850Z61057, 850Y61016, 85EX67016, 85EA67066, 85EX67004, 850Z61029, 850Z61031, 85EX67011, 85EX67010, 850Y61013, 850Y61015, 850Y61017, 850A61070, 85EX67005, 850A61073, 85EX67018, 85EY67033, 850Z61027, 85EX67013, 850Z61054, 850X61001, 85EZ67053, 85EZ67054, 85EZ67057, 850X61004, 850Z61059, 850Z61052, 850Y61014, 850Z61048, 850Y61026, 850Y61019, 85EY67044, 850Z61037, 850X61002, 85EX67003, 85EX67014, 850Y61007, 85EY67049, 85EZ67052, 850A61067, 850A61074, 85EY67050, 85EZ67051, 85EY67027; UDI/DI (01)00840682140775(21)850B61120(11)220700, Serial Numbers: 850B61120; UDI/DI 010084068214077521850Y6101111190300, Serial Numbers: 850Y61011; UDI/DI To be provided, Serial Numbers: 850A61083, 85EA67080, 850B61127, 850B61128, 850B61129, 850B61130, 85EB67087, 850B61133, 850B61134, 850B61135, 850B61101, 85EA67070, 850B61119, 850B61102, 850B61115, 85EA67076, CHBB65669, 850B61122, 850B61132, 850B61131, 85EA67075, 85EA67077, 85EB67088, 850A61093, 85EB67086, 850B61126, 850A61089, 85EA67078, 850B61112, 850B61111, 850B61110, 850B61107, 850B61109; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 60B62111; d) 860 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2100006BH; e) 860 3/8 inch NM Gantry: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Y62009, 860Y62010, 860Z62027, 860Y62005, 860A62049, 860Y62019, 860Y62014, 860Y62025, 860Z62028, 860Y62024, 860Z62038, 860A62063, 860Z62042, 860Y62017, 860A62065, 860A62058, 860Z62046, 860A62057, 860Z62041, 86EA76004, 860B62118, 860Z62043, 860A62060, 860Z62026, 860Y62006, 860Y62015, 860Y62004, 860Z62047, 860Y62020, 860A62050, 860Z62030, 860Y62007, 860X62002, 860Z62032, 860Y62021, 86EA76003, 860Z62040, 860Z62037, 860Z62031, 860A62062; , UDI/DI 010084068214075121860A6207711211000, Serial Numbers: 860A62077; UDI/DI (01)00840682140751(21)860B62097(11)220300, Serial Numbers: 860B62097; UDI/DI 010084068214075121860B6209611220300, Serial Numbers: 860B62096; UDI/DI 010084068214075121860A6205911210400, Serial Numbers: 860A62059; UDI/DI 010084068214075121860A6206811210600, Serial Numbers: 860A62068; UDI/DI 010084068214075121860Y6202311191100, Serial Numbers: 860Y62023; UDI/DI 010084068214075121860Y6201311190600, Serial Numbers: 860Y62013; UDI/DI To be provided, Serial Numbers: 860A62067, 860Y62016, 860B62117, 860B62100, 860B62105, 860B62090, 860A62072, 860B62108, 860B62110, 860A62078, 860A62083, 860B62094, 860A62066, 860A62084, 860A62071, 860A62070, 860A62073, 860A62069, 860B62095, 860A62086, 860A62081, 860A62085, 860B62099, 860B62115, 860A62082, 860B62114, 860A62074, 860Z62034, 86EB76006, 860B62122, 860B62119, 860B62121, 860B62089, 86EB76007, 860A62076, 860A62079, 860B62116, 86EB76009, 860B62120, 860B62093, 860A62080, 860B62098, 860B62091, 860B62103; f) 860 5/8 inch NM Gantry: Catalog number H3908AE, UDI/DI To be provided, Serial Numbers: 860X62001; , UDI/DI Not Applicable, Serial Numbers: 860Z62035; g) 860 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG1900007BH, NT3CG1900008BH, NT3CG1900009BH; h) NM 830 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3AG1900007BH, NT3AG2100001BH, NT3AG2100006BH; i) NM/CT 850 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2000003BH, NT3BG2100001BH, NT3BG2200001BH, NT3BG1900001BH, NT3BG2200002BH, NT3BG2000004BH, NT3BG2100004BH, NT3BG2200005BH; : Catalog number H2407AA, UDI/DI Not Applicable, Serial Numbers: NT3BG2000001BH; , UDI/DI To be provided, Serial Numbers: NT3BG2100002BH; : Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2000002BH; j) NM/CT 850 3/8 inch ROW: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2100005BH, NT3BG1900002BH; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Y61022, 850Z61046, 850Y61008; UDI/DI To be provided, Serial Numbers: 850B61100; k) NM/CT 850 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860Y62008; l) NM/CT 850 CT 850 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850A61092, 850B61108, 850B61096, 850A61080, 850Z61050, 850B61106, 850B61097, 850A61077, 850B61118, 860B62112; Catalog number 5376204-50, UDI/DI 010084068214077521850A6109511211200, Serial Numbers: 850A61095; UDI/DI 010084068214077521850A6108811210900, Serial Numbers: 850A61088; UDI/DI 010084068214077521850B6112111220700, Serial Numbers: 850B61121; UDI/DI 010084068214077521850B6110411220400, Serial Numbers: 850B61104; UDI/DI 010084068214077521850A6108711210900, Serial Numbers: 850A61087; UDI/DI 010084068214077521850A6108211210800, Serial Numbers: 850A61082; UDI/DI 010084068214077521850B6110511220400, Serial Numbers: 850B61105; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 850A61081; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Z61049, 850A61066; UDI/DI To be provided, Serial Numbers: 850B61098, 850B61099, 850A61084, 850B61123, 850B61113, 850B61117, 850B61116, 850A61090, 850A61079, 850A61091, 850B61114, 850A61078, 850A61086; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 850B61125, 850B61103; m) NM/CT 850 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 85EA67068; Catalog number 5376204-50, UDI/DI 01008406821407752185EA6707411210800, Serial Numbers: 85EA67074, 85EA67067, 85EA67073; Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3BG1900003BH; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 85EA67071; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EX67007; UDI/DI To be provided, Serial Numbers: 85EA67069, 85EA67072, 85EA67079, 85EB67084; n) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EZ67059, 85EA67064, 85EY67034; o) NM/CT 860 3/8 inch: Catalog number H3908AD, UDI/DI To be provided, Serial Numbers: 00000860Z62033; p) NM/CT 860 3/8 inch BJ: Catalog number H2408AA, UDI/DI To be provided, Serial Numbers: NT3CG2000001BH; Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2100001BH, NT3CG1900010BH, NT3CG2100003BH, NT3CG1900005BH, NT3CG1900003BH, NT3CG2100004BH, NT3CG1900006BH, NT3CG2100005BH, NT3CG2000004BH, NT3CG1900002BH, NT3CG2100002BH; q) NM/CT 860 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 00000860Y62018; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860A62056, 860Y62011, 860A62048, 860Z62039, 860Z62044, 860A62052, 860A62055, 860Y62012, 860Y62022, 860A62054; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2000003BH; UDI/DI To be provided, Serial Numbers: 860B62102; r) NM/CT 860 ADVANCE: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62045, 860A62064, 860A62061; UDI/DI To be provided, Serial Numbers: 860A62075; Catalog number H3908BB , UDI/DI Not Applicable, Serial Numbers: 8BBB30002, 8BBB30001; s) NM/CT 860 advance 3/8 inch NM Gantry: Catalog number H3908BB, UDI/DI To be provided, Serial Numbers: 8BBB30003, 8BBB30004; t) NM/CT 860 BEYOND: Catalog number H3908BC, UDI/DI Not Applicable, Serial Numbers: 8BCB40001; u) NM/CT 860 beyond 3/8 inch NM Gantry: Catalog number H3908BC, UDI/DI To be provided, Serial Numbers: 8BCB40002; v) NM/CT 860 China for China: Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2200004BH, NT3CG2200003BH, NT3CG2200002BH; , UDI/DI To be provided, Serial Numbers: NT3CG2200001BH; w) NM/CT 860 CT 860 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860B62109, 860Z62029, 860B62101, 860B62113; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62036, 86EZ76001, 860A62053; UDI/DI To be provided, Serial Numbers: 860B62092, 860A62088; x) NM/CT 860 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 86EB76005; y) NM/CT 860 ES 3/8 inch ROW: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 86EA76002; z) NM/CT 850 3/8 inch: Catalog number H3907AA, UDI/DI Not Applicable, Serial Numbers: 850Y61024; aa) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AH, UDI/DI Not Applicable, Serial Numbers: 85EY67030; bb) NM/CT 860 3/8 inch CH: Catalog number H2408AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1900007BH; cc) XELERIS 4 DR WORKSTATION: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850B61124, 850A61094

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91456
Status: Active
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Manufactured In: Israel
Units Affected: 6 products (557 units; 748 units; 7 units; 34 units; 86 units; 380 units)
Agency Last Updated: February 16, 2023

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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