FDA · Medical device recall

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System and 3 more products

April 13, 2022 Class II

Date: April 13, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: There is potential for the images to be flipped left to right.
Distribution pattern: 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.

4 products in this recall

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

Product: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Quantity: 10 units
Codes and lots: System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
Recall started: Feb. 18, 2022
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Device Design
What the company told customers: 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 number: Z-0857-2022

1.5T SIGNA Excite HD…

Product: 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Quantity: 76 units
Codes and lots: 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
Recall started: Feb. 18, 2022
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Device Design
What the company told customers: 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 number: Z-0858-2022

SIGNA Excite 3T…

Product: SIGNA Excite 3T. Magnetic Resonance Imaging System
Quantity: 55 units
Codes and lots: 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
Recall started: Feb. 18, 2022
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Device Design
What the company told customers: 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 number: Z-0859-2022

1.5T and 3.0T SIGNA HDx…

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
Quantity: 653 units
Codes and lots: 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
Recall started: Feb. 18, 2022
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Device Design
What the company told customers: 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 number: Z-0860-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0857-2022, Z-0858-2022, Z-0859-2022, Z-0860-2022. The agency record governs; check it and the company before acting.

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