GE Medical Systems, LLC: 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Hazard

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Details from the source

Reason for recall: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. Distribution: Worldwide distribution. Quantity: 2146 units Lot/code info: System ID: 907373VMR, 256SPMR2, 870642MR, 5340995MR11, KRMCMR2, SMSCIA2, 714229MR2, SHIMR02637, 310358VMR, RADNETMR664, 559447MRVOYA3, 559447MRVOYA2, 559447MRVOYA1, INSIGHTMR1397, 626359VMR4, INSIGHTMR1371, ALLIANCEVOYA04, 707431MR, 323294VMR, 310823VMR, SHIMR02636, 818496HCMR1, 209SUTBMR, SHIMR02625, SHIMR02617, 530OROMMR, SHIMR02645, INSIGHTMR1385, INSIGHTMR1378, SHIMR02647, 13412, SHIMR02648, SHIMR02635, SHIMR02654, RADNETMR648, SHIMR02639, ALLIANCEVOYA11, INSIGHTMR1376, SHIMR02650, SHIMR02638, SHIMR02624, 818708MR2, 707462VOYMR, 661HMVMR1, 760247VMR, SHIMR02653, 303750MR, 307630MR2, 719394MR, 970242VAMR, 3036140MR, 720513MR, 970879VMR, 860289VOYAGER, 860659MRVOYAGER, 203453VOYAGER, 860347VOYAGER, 203834VOYAGER, 302655MR1, 561996MR1, 813315MR, 352597MR1, ALLIANCEVOYA01, 305445MR1, 904CSMR, 904627MR3, SHIMR02652, 321CLMRVOY, 305229MR1, 239NHVOY, 352ADVMR, 352867MR2, 941MPGPGVOY, 813655MR, 813874MR1, 941VOYMR, 850325MR1, 850877MR1, 229758MRI, 770539MR, MSF138-1-6XIAHPU7, 478745VMR, 229329MRI, SMSVIT7, SMSSVM8, SMSZOE3, SMSKIT1, SMSSVM1, SMSMAG1, SMSCAM2, SMSAMP1, SMSOMR1, 712737MRVOY, SMSWES4, 319352MR, SMSOAK2, 208735VOYMR, SMSCIA1, SHIMR2667, 618GOSHENMR, 847931MR, DSSMR5, SMSCAM1, 1000003628, 217QMGVOYAGER, SMSOMR5, 847252MRI, SMGMR59, DMSMR166, SMSZAG1, 812348MR2, 317415VOY, 574537MR, 574647VOYAGER, 574271MR, 812663MR2, 317899MR, 812283MR, SMSOMR2, SMSSVM4, SMSSVM3, 316613MR, 606833MRW2, DSSMR6, 606598MR2, 985ONCMR2, 4600722-MSF116-1-1-1, 985FWMR, SMGMR44, 337593VOYAGER1

UPC codes

83169743687, 83178031584, 082427110138, 082427040313, 082427040321, 082427040326, 082427040331, 082427040241, 082427220142, 082427220135, 082427220107, 082427220088, 082427040315, 082427220110, 082427140307, 082427140202, 082427270088, 082427140267, 82427090504, 082427210249, 082427210240, 082427230255, 082427130112, 082427160336, 082427040266, 082427210203, 082427200193, 082427140209, 082427310146, 082427140217, 082427140213, 082427110111, 082427100391, 082427230189, 082427090376, 82427140341, 082427140301, 082427140251, 082427140214, 082427140191

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.