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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

GE Healthcare, LLC: There is potential for the images to be flipped left to right.

Agency Publication Date: April 4, 2022
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Affected Products

Product: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR

Product: 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

System IDs: 928223MR3T, 360397MR2, 602406IMR, 480323MR1, 928SMIMR, 3825, 559325CIIMR1, 805988MR2, 6617263TMR, 650306SMR3T, 4036, 3600, 3266, 818RIMR3T, 4267, 352333MR3T, 407SOMR3T, 941PCMR, 386HPOMR, ALLIANCESIG463, 337261MR1, 601288MR3T, 662841MR4, 336713WFUMR, 609383MR, 201487MR, 805998MR1, 805998CR1, 702369SM3TLV, 405634S3T, 814234MR, 6053883T, 731425MR2, 901425MROP1, 806212MR3T, 409892SMR2, 972566MR3, 972378NSC3TMR1, 801377MR2, 910277003, 2577595, 082427090088, 082427210045, 082427270017, 082427160041, 082427040047, 082427040052, 082427040074, 082427210039, 082427090090, 082427310027, 082427100093, 082427140039, 082427030039, 082427100099, 082427100084, 082427070050, 082427070034, 082427310019, 082427100089, IR1503MR01, A5125121, A5806911, YM3034, 850270175, 850270176, 850270199, 850270361, 850270205, KW1004MR03, RF0754MR01, GEE34040, 0853270071, 0853270072, 34208MRS01, 34006MRS03

Product: SIGNA Excite 3T. Magnetic Resonance Imaging System

System IDs: 3422, 209577MRMOBX, 407303CHMR, SIMONVILLAGES3T, 321MR3T3, 321MR3T2, 407999MR3T, 316268TWIN3, 8109873T, 732473MR, 702433SIM3T, 864573MBMR2, 901726OPMR, 214879INVIVO, 817578LGMR2, 972665XDDAMR1 2284SIG15T, 47413, 2550000, 975, 604270MR3T, 416813MR3, 416369MR2, 082427130025 082427130020, 082427130022, 082427270012, 082427270011, 082427150025, 082427020020, 082427010032, 082427160051, 082427160050, 082427120042, 082427120027, 082427030037, 082427250016, 082427070046, 082427150026, 082427090035, 082427140034, 082427140040, 082427090044, 082427100075, 082427120029, 082427070049, 082427070048, 082427220010, 082427300008, YM1408, YM1414, YM1406, 850270152, LB1049MR02, PK1184MR01

Product: 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

System IDs: 907562P3T, 256734MR3T, 623879MR1, 623433MR1, 480584MR1, 602689MR1, 9287573TMR, 480324MR1, 480614MR1, 928317MR1, 714868MR1, RADNETMR615, 714619MR, 5107923TMR, 858657MR1, 323442MR3, 323442MR1, 213977MR2, 323932MR1, 323442MR2, RADNETMR612, 650259SM3T, RADNETMR1521, RADNETMR592, 626397MR2, RADNETMR620, 916DR3TMR, 415UCLPMR, 415600D3T, 415476UMR6, 415353MRC1, 415MTZMR, 408GS3TMR, RADNETMR1595, 408885MR3T, RADNETMR608, 805569MR, 415723SHMR8, 661AIMR2, RADNETMR594, 805CHLIMR1, 720848MR2, 303340MR, 030022MR01, 515282MR1, 859275MR3T, 2709263HD, 504873TMR3, 504DISWMR, 504DISMR3T, BEV3TMR, 9786823T, RADNETMR1659, RADNETMR1589, 207MMCSMR, 517353VH3, 269342MR3T, 269342MR3T2, 517374MR3T, 248465MR3T, 248849MR3T, 662MSU3T, 406751K3T, CONCORD3T, 201669MR2, 716859MR3T, NYP347652, 212305MR83T, 5857853T, 631686MR3T, 5853413TLAC, 419383MR3T, 503280MR2, 6109883TMR, 423844MR2, 865541MR3T, 615777MR3T, 936441MR1, 817882H3TMR, 513556MR, 713441MR5, 512TSIMR2, 210617TCAMR2, 210617TCAMR1, 801221MR, 509758TMR, 425288CMR, 2063203TMR, 414973MR2, 608785HDMR, 414649MR5, 414973MR1, 422SIGNA3T, 250374MRTS, 604682MRI, 604682MRI2, 604739MR, 082427120201, DK1030MR02, ET1009MR01, 493013MR01, HC1819MR01, 850270170, 850270218, MR281340MR0, DVT0127, PER19516, PER08626, RU1095MR03, ZA2222MR01, MPX82251, GP178328, FPG98423, FPG98415, MEX68900, DPN88605, ME051580, MPX10000, EPP00302, 725030MR01, 00149MRS01, 205939MR4, 205783TSMR, 2059393T, 928213MR3T, 480354MR1, 602588CMR1, 480464MR1, 4809643TMR, 954SIMON3T, 480478MR1, 602406MR6, 831423MR, 4802643TMR, 480425MR5, 480264MR2, 5204493T, RADNETMR590, 310623MR, 626359MR3, 760ENCMR, RADNETMR627, 213777MR, 323268MR2, 213387MR, 510MIA3T, 951SWMR, 805GI3T, 760323MR3T, 650FALK3TMR, 650853PAMR2, RADNETMR617, RADNETMR646, 909806MR, 559585CCICMR2, 916UCDMR3T, 916KM3TMR, RADNETMR609, 858453VMR2, 858822MR3, 4419, RADNETMR1706, 510939JMMR3T, 626962MR, 303SMIMR1, 303633MR, 970244MR3T, 719542MR, 719595MR, 860659MR, 203863MR3T, 860545MR2, 860231MR, 202865MR3T, 407BDIMR, 3173383T1, SIMONMED3TBRANDON, 850916A3T, 407OSCMR3T, 239307MR, NCHMBMR3T, 904276OPTS, PRMTMR3T, 850475IC3T, 727440MR1, 727898MR1, 412692MR1, 813251MR3T, 813972MR3T, 772VRAMR3T, 407SMWPMR1, 7067213TMR, 7705353TMR, 404772NMR3T, 808591MR, 3096653TMR, 773665MR3T, 847SAMC3T, 708383WS3T, 309672MR3T, 859313MR, 225763MR, RADNETMR1636, 301459MR, 410535MR, 410543MR, 3137453TMR, 269341MR3T, 313294MR, 248551MR3T, 2489643T, 9525413TMR, 612626MR3T, 2187493T, 573815BMR1, 636947JMR1, 601268MR3T, 910609CF3T, 402219MR3T, 908725MR, 7326133T, 201632MR, 732632MR3, 609652MR3T, 732223MR, 609497MR3T, 919684MR3, 7024230SM3THL, M48823, RADNETMR554, COR373219, RADNETMR1583, 631982MR, 405CDIMR, 503652MR1, 503216MR3, 503215MR1, 717975MR3, 6053383TMR, 6053223TMR, 731935MR3, 865218MR3T, 901572L3T, 615284MR3T, 615TANMR, 865481MR3T, 865545MR3T, 806NWTH3TMR, 214559SRHMR1, 214329PHIMR1, 214341PDGPMR1, 281333MR1, 713524BIMR1, ACB41121MR, 713704HMR4, 212288GE3T, ACB41109MR, 972665XBPMR1, 210804SUNMR, 801373MR3, 435688MR3, 801321LMR2, 70389MR3T, 703573MR6, 8047643T, 8043303T, 540776MR3, 425297RMR, 304636MR, 304526CMR2, 16683THDX, 2901847MR3T, 910272046, 910273033, 83160776416, AZ4013MR01, BA4080MR01, 2885417, 2854971, MRR8701, 2766544, 2806189, 2871974-1, MRR9017, MRR2396, MRWB0540, 604557MR1, 905522MR, 902678MR1, 416369MR3T, 519254MR, 082427090190, 082427040149, 082427110026, 082427090170, 082427080033, 082427100192, 082427170011, 082427170012, 082427130067, 082427070069, 082427070120, 082427310042, 082427130090, 082427130046, 082427130044, 082427130084, 082427130059, 082427130061, 082427130083, 082427130062, 082427130042, 082427130077, 082427160081, 082427160105, 082427080051, 082427100220, 082427100201, 082427100173, 082427030115, 082427270016, 082427200052, 082427270030, 082427070054, 082427090115, 082427290013, 082427040101, 082427040105, 082427040088, 082427040113, 082427040147, 082427040099, 082427040100, 082427040092, 082427120070, 082427120102, 082427150051, 082427200056, 082427200036, 082427120086, 082427010074, 082427110042, 082427110025, 082427110034, 082427020037, 082427090174, 082427060051, 082427060063, 082427060032, 082427060025, 082427010054, 082427090246, 082427090292, 082427080044, 082427010038, 082427250060, 082427030106, 082427040094, 082427050027, 082427080026, 082427100172, 082427190049, 082427140150, 082427090171, 082427090164, 082427240019, 082427210063, 082427270022, 082427160159, 082427160084, 082427160110, 082427160065, 082427160064, 082427160113, 082427070062, 082427020065, 082427070055, 082427070116, 082427120091, 082427120199, 082427160117, 082427230068, 082427090335, 082427090245, 082427120126, 082427120062, 082427120077, 082427100153, 082427250088, 082427250067, 082427250030, 082427270040, 082427270032, 082427140134, 082427140120, 082427140062, 082427020025, 082427210049, 082427210053, 082427210070, 082427210060, 082427210058, 082427240048, 082427310046, 082427160103, 082427030042, 082427030116, 082427030050, 082427150056, 082427100228, 082427090288, 082427090124, 082427100126, 082427100161, 082427100176, 082427170008, 082427100102, 082427160203, 082427160072, 082427140067, 082427140051, 082427140077, 082427110047, 082427110044, 082427100164, 082427100198, 082427100185, 082427160070, 082427010077, 082427010093, 082427010095, 082427010069, 082427120093, 082427030071, 082427070063, 082427150103, 082427150040, 082427150048, 082427070101, 082427160272, 082427110027, 082427120072, 082427200072, 082427030090, 082427030064, 082427190066, 082427210127, 082427280002, 082427310108, 082427310032, 082427310029, 082427310048, 082427310034, 082427240041, 082427200039, 082427060028, 082427060038, 082427120083, 082427020041, 082427240030, 082427240070, 082427090139, 082427090208, 082427090229, 082427090267, 082427090227, 082427090263, 082427090238, 082427090134, 082427090141, 082427090226, 082427090289, 082427090232, 082427190078, 082427060034, 082427220018, 082427220041, 082427220016, 082427030056, 082427030086, 082427300010, 082427300014, 082427300018, 082427300012, 082427020026, 082427190075, 082427190069, 082427100119, 082427100309, 082427100182, 082427090173, 082427010141, 082427010047, 082427010150, 082427240034, 082427010065, DK1018MR01, ET1293MR02, S41600123, HC0074MR01, MC6946MR07, H10392MR03, H2193MR05, 0828270039, 083027828659711, 083027041002010, 083027601000510, 083027609389015, 083027605826311, 083027202000249, 083027024220111, 083027022101691, 083027202001698, 083027202101396, 083027207848338, 083027002101567, 083027006495511, 083027002101706, 083027009445910, 083027007755738, 083027002730811, 083027202101819, 083027243783711, 083027862100837, IE1111MR01, A469231301, A5632416, C5323526, YM1404, YM1261, YM1799, YM0867, YM3040, YM0873, YM1836, YM1839, YM2021, YM1851, YM1837, YM1831, YM1817, YM1832, YM1821, YM1401, YM3900, YM1805, YM1395, YM3883, YM1815, YM1841, YM3032, YM1797, YM1794, YM1881, YM1796, YM1788, YM1842, YM1834, YM1840, YM1800, YM1882, YM1813, YM1812, YM1850, YM1823, YM1843, YM1810, YM1845, YM1820, YM2018, YM1400, YM0796, YM0790, YM1870, YM0888, YM3042, YM1804, YM1880, YM1877, YM2003, YM1808, YM0802, YM1411, YM1798, YM1819, YM1809, YM1822, YM0801, YM1848, YM1828, YM1844, YM1792, YM1793, YM1402, YM1818, YM2020, YM1824, YM1846, YM0791, YM1879, YM1399, YM1826, YM1849, YM1847, YM3939, YM0872, YM2005, YM1827, YM1803, YM2012, YM1835, YM1816, 850270200, 850270202, 850270333, 850270220, LB1000MR02, 2716757SIGNAHX, 920279024, PL3800MR01, PL3545MR01, PL1050MR01, PL3040MR01, PL3546MR01, PER28007, 787641HDXT, RO1189MR01, RU1588MR01, RU1087MR01, RU1089MR04, RU1067MR02, RU1688MR01, RU9155MR02, RU1884MR01, SA1012MR01, SA1001MR03, RS4202MR01, SI4024MR02, ZA2169MR01, DEL26444, CEN03406, DPC79014, DEN51500, NPV84502, G002MR01, SY2012MR02, 0853270074, 0853270095, 0853270081, 0853270094, 0853270088, AE1190MR01, 70328MRS04

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89720
Status: Active
Manufacturer: GE Healthcare, LLC
Manufactured In: United States
Units Affected: 4 products (10 units; 76 units; 55 units; 653 units)
Agency Last Updated: September 8, 2022

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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.