GE Healthcare, LLC: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

Agency Publication Date: May 3, 2019

Affected Products

Product: Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM ope

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH 630X22925 310657D630 H3100JY 630X22921 951682NMDISC H3100JY 63GY50067 719776DISCNM H3101RH 63GX50001 863494NM H3101RH 630X22923 904296NM H3100JY 63GX50037 305223D630A H3101RH 63GX50060 305223D630B H3101RH 63GX50034 478289DIS H3101RH 63GX50014 618998NM H3101RH 63GX50019 270745NM1 H3101RH 63GY50078 269966NMDISC H3101RH 63GX50021 906225CARDNM2 H3101RH 63GX50022 906225CARDNM1 H3101RH 63GX50018 269637NM630 H3101RH 63GX50009 NM555658 H3101RH 63GY50080 4695517NM11 H3101RH 63GY50077 919954NMDISC H3101RH 63GX50043 828286RHD630 H3101RH 63GX50020 402481D630C H3101RH 63GX50040 973450CARD630 H3101RH 63GX50054 973450D630 H3101RH 63GX50008 856641NM H3101RH 63GY50079 SHIPPED (GON 4722927) H3101RH 63GX50061 702962NM1 H3101RH 63GX50035 702962NM2 5376204-31 63GX50050 702388DISC H3101RH 63GX50062 702724DISCNM H3101RH 63GX50032 513861NM H3101RH 63GX50055 513861NM1 H3101RH 63GX50013 740MGD630 H3101RH 63GX50047 440743D630 H3101RH 63GX50002 419251NM H3101RH 63GX50025 330841DISCNM H3101RH 63GX50033 330841DISCNM2 H3101RH 63GX50038 918756D630 H3101RH 63GX50044 803865D630 H3101RH 63GY50068 854529NMDISC H3101RH 63GY50069 901516NM 5376204-31 63GX50016 615873NM H3101RH 63GY50075 SHIPPED (GON 4561460) H3101RH 63GX50012 832505D630 H3101RH 63GX50005 713440NM630B H3101RH 63GX50029 281MHNE630 H3101RH 630X22919 972258NM630 H3100JY 63GX50046 210351NM H3101RH 63GX50049 281MWL630B H3101RH 63GX50039 281MWL630A H3101RH 63GX50030 434243DIS H3101RH 63GX50011 LGMONT630 H3101RH 63GX50017 540316NM630 5791570 630X22922 804764D630C H3100JY 630X22924 UESS01NU03 H3100JY 63GX50048 418404NU02 H3101RH 63GX50041 083026202460918 H3101RH NT2PG1800001BH NT8003 5376204-31-1

Lot Numbers:

63GY50074

Product: Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and f

Mfg. Lot or Serial # System ID AD7X38019 250727D670 AD7X38022 C5323544 AD7X38020 00433NUC11

Product: Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and

Mfg. Lot or Serial # System ID Model, Catalogue or Code # DRGX56002 SHIPPED (GON 4683652) H3100BT DDRX34058 909558D670NM H3100AN DDRX34056 650723D670 H3100AN DDRX34053 SHIPPED (AO 1614951) H3100AN DRGX56005 614CVA6702 H3100BT DRGX56017 110002NU06 H3100BT DRGX56004 403343D670A H3100BT DRGX56018 X7410502 H3100BT DRGX56009 083026206531618 H3100BT DRGX56012 STD01300 H3100BT DDRX34055 00362NUC04 H3100AN

Lot Numbers:

DRGX56002

Product: Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and

Mfg. Lot or Serial # System ID Model, Catalogue or Code # ESDX35020 403777D670C H3100BL ESPX54001 A51773134 H3100BM ESPY54002 DE203284 H3100BM

Lot Numbers:

ESDX35020

Product: NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation con

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 830Y60040 256737NM H3910AC 830X60004 901227NM1 H3910AC 830X60001 479338N830 H3910AC 830Y60036 860496NM830 H3910AC 830X60018 772468NM830 H3910AC 830X60026 954721NM H3910AC 830X60012 813315D830 H3910AC 830Y60030 813874D830 H3910AC 830X60011 225761NM1 H3910AC 830X60016 225761NM H3910AC 830Y60029 410554NM H3910AC 830X60019 573458NM H3910AC 830X60027 603742NM830 H3910AC 830X60014 718238D830 H3910AC 830X60015 585396NM H3910AC 830X60006 716862NM830 H3910AC 830Y60031 631726D830 H3910AC 830X60003 585786NM830 H3910AC 830X60021 615316NM830 H3910AC 830Y60034 936CMC830 H3910AC 830X60028 361275NM830 H3910AC 830X60017 956323NM830 H3910AC 830Y60035 304526D830 H3910AC 830X60002 100039NU05 H3910AC 830X60022 705743DNM830 H3910AC 830X60013 M4040557 H3910AC 830Y60032 362759NU01 H3910AC 830Y60033 NS0103 H3910AC 830Y60038 NS0104 H3910AC NT3AG1900002BH NS0204 5376204-32-1 NT3AG1900003BH NS0205 5376204-32-1 NT3AG1900001BH NS0203 5376204-32-1 NT3AG1800001BH NS0201 5376204-32-1 830X60020 NS0101 H3910AC 830X60005 0850260165 H3910AC 830X60008 0850260166 H3910AC 830X60007 752030NU01 H3910AC

Lot Numbers:

830Y60040

Product: NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 85EX67018 4740081NM11 H3907AD 85EX67001 203789NM850 H3907AD 850X61005 319768NMCT H3907AD 850Y61006 319768NMH988 H3907AD 85EX67022 847618NM H3907AD 85EX67019 773975NMCT H3907AD 85EX67008 779696NM850 H3907AD 85EX67017 318212NM H3907AD 85EX67012 781729NM H3907AD 85EX67015 SHIPPED (AO 1623723) H3907AD 85EX67020 SHIPPED (GON 4745963) H3907AD 85EX67023 SHIPPED (GON 4704278) H3907AD 85EX67024 SHIPPED (GON 4710759) H3907AD 85EY67025 SHIPPED (AO 1638499) H3907AD 85EY67026 SHIPPED (AO 1638498) H3907AD 85EY67028 SHIPPED (AO 1638502) H3907AD 85EX67009 513732NM 5782013 85EX67002 419289D850 H3907AD 85EX67016 972969NM H3907AD 85EX67004 571472NM850 H3907AD 85EX67021 SHIPPED (GON 4640067) H3907AD 85EX67010 804289NM850A H3907AD 85EX67011 804281NM850A H3907AD 85EX67005 715717NMCT H3907AD 85EX67013 920456NM H3907AD 850X61004 030601NU06 H3907AD 850X61002 NS0001 H3907AD NT3BG1900001BH NS0401 5376204-50-1 85EX67003 PL1692NM05 H3907AD 85EX67014 PPR59076 H3907AD 850Y61007 SK1082NM02 H3907AD

Lot Numbers:

85EX67018

Product: NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Comp

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 860Y62005 SHIPPED (GON 4736850) H3908AD 850X61003 401793860NM H3908AD 860X62001 E6843969 H3908AE 870X64005 HC4387NU05 H3100AS 860Y62004 083026212959219 H3908AD 860X62002 PL0399NM01 H3908AD

Lot Numbers:

860Y62005

Product: NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for stand

Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 190020NU01 87CX63006 030240NU11 87CX63015 705743NM870 87CX63011 M4184879 87CX63003 M9886873 87CX63004 X171582003 87CX63009 M171582018 87CX63010 UC1796NU01 87CX63013 NO1068MN18 87CX63005 A004NU20 87CX63002 C028NU01 87CX63012 C028NU02 87CX63001 900010NU12

Product: NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitori

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 870Y64037 SHIPPED (GON 4566933) H3100AS 870Y64040 SHIPPED (GON 4751375) H3100AS 870X64011 216844DR870 H3100AS 870X64024 802775D870 H3100AS 870X64002 206SCCANM H3100AS 870X64032 262741NUC H3100AS 870X64001 030020NU06 H3100AS 870Y64034 514345BD870 H3100AS 870Y64035 M54606132 H3100AS 870X64012 X634445001 H3100AS 870X64007 V2728113 H3100AS 870X64009 M4016255 H3100AS 870X64026 M40230109 H3100AS 870X64017 M40240121 H3100Q 870X64018 M40240122 H3100Q 870X64016 499221NU01 H3100AS 870X64022 A5173220 H3100AS NT3DG1800003BH NS0303 5376204-70-60-1 NT3DG1800002BH NS0302 5376204-70-60-1 870X64025 EMM0530 H3100AS 870Y64038 MST01300 H3100AS 870X64029 PL1031NM01 H3100AS 870X64027 PL0398NM01 H3100AS 870X64030 PL2190NM01 H3100AS 870X64028 PL0372NM01 H3100AS 870X64013 NP473631 H3100AS 870X64008 00669NUC03 H3100AS

Lot Numbers:

870Y64037

Product: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.

Mfg. Lot or Serial # System ID Model, Catalogue or Code # ONMX26520 714456OPT1 5474055 ONMX26518 408559O640 H3100JZ ONMX26529 408559O640 H3100JZ ONMX26528 970298NM 5474055 ONMX26537 303425O640 5474055 ONMX26538 303689O640 5474055 ONMX26539 970298NM1 5474055 ONMX26519 860358O640 H3100JZ ONMX26530 302430NUC640 H3100JZ ONMX26512 515699NM1 H3100JZ ONMX26503 630933NM6402 H3100JZ ONMX26513 316962NM640 H3100JZ ONMX26511 443777NM 5474055 ONMX26542 301315NMOPTIMA H3100JZ ONMX26510 906225NMCT H3100JZ ONMX26514 4695537NM11 H3100JZ ONMX26507 RMCOPTIMA H3100JZ ONMX26515 701239NM640B 5474055 ONMX26534 402473OPT640 H3100JZ 64GX51001 SHIPPED (GON 4562299) H3101RL 64GY51006 SHIPPED (AO 1635868) H3101RL 64GY51007 SHIPPED (GON 4562663) H3101RL ONMX26544 740593OPT640 H3100JZ ONMX26531 614MCMN640 5474055 ONMX26517 513870NM640 H3100JZ ONMX26524 614GCNM6402 5474055 ONMX26527 614GCNM640 H3100JZ ONMX26546 605347NM640 H3100JZ ONMX26516 469993NM H3100JZ ONMX26476 608263OPT640 H3100JZ ONMX26480 403529D640 H3100JZ ONMX26502 4534444NM12 H3100JZ ONMX26536 HR4052NM03 H3100JZ ONMX26521 NTE042 H3100JZ ONMX26525 ZA2719CT01 H3100JZ

Lot Numbers:

ONMX26520

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82582

Status: Resolved

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 10 products (57 units; 3 units; 11 units; 3 units; 37 units; 31 units; 6 units; 16 units; 27 units; 35 units)

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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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers:

63GY50074

Mfg. Lot or Serial # System ID AD7X38019 250727D670 AD7X38022 C5323544 AD7X38020 00433NUC11

Lot Numbers:

DRGX56002

Mfg. Lot or Serial # System ID Model, Catalogue or Code # ESDX35020 403777D670C H3100BL ESPX54001 A51773134 H3100BM ESPY54002 DE203284 H3100BM

Lot Numbers:

ESDX35020

Lot Numbers:

830Y60040

Lot Numbers:

85EX67018

Lot Numbers:

860Y62005

Lot Numbers:

870Y64037

Lot Numbers:

ONMX26520