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U.S. Department of Health and Human Services

Class 2 Device Recall 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile

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  Class 2 Device Recall 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile see related information
Date Initiated by Firm February 18, 2022
Date Posted April 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0860-2022
Recall Event ID 89720
510(K)Number K052293  K121676  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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
Code Information 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
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 There is potential for the images to be flipped left to right.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 653 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
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