1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T… recallZ-0860-2022 · GE Healthcare, LLC · initiated Feb 18, 2022
Class II Open, Classified All recalls posted in April 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for the images to be flipped left to right.
FDA root cause category: Device Design
What the company is doing
This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions and link for customer to access and download the revised service manual.
Recall details
- Recall number
- Z-0860-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 18, 2022
- Posted by the FDA
- Apr 4, 2022
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 653 units
- Product code
- LNH
- FDA submissions
- K121676, K052293
- Distribution
- Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product description
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Code information (models, lots, serial numbers)
Show the full code information (8k characters)
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
Other devices under the same FDA submission
1 device cleared under K121676, K052293 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1.5T SPLIT HEAD COILGE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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