FDAFDA · Food and drugs·Recall number Z-2460-2024
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Published August 14, 2024 · Recall initiated: June 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, LLC
- Distributor
- Worldwide distribution.
- Lot
- System ID: 520744MR, 714578MR1, RADNETMR1727, RADNETMR652, 951486MR2, RADNETMR651, 831RMGMR1, RADNETMR647, RADNETMR661, 720442MR, 303508MR, 860584MR3T, 203694MR3T, 860678MR3T, 860545MR3T, 860536MR3T, 203327MR3T, 860871MR3T, 203949MR3T, 305933MR1, 954489MR2, 954492MR1, 407ODMR3T, 863577MR, 863607MR, 386385MR1, 850696MR3T, 954423MR2, RADNETMR1700, 850877PNR, 706PIONEER, 847459MR, 815215FDMR, 217223BHMR3T, 217QMG3TMR, 574SBOPIONEER, 318769MR2, 504LCMCHMR, 985WCMR3, 508872PMR, 508998MR, 413SHMR3T, 508775MR1, 781331MR, 508756PMR, 410266MR5, RADNETMR1719, RADNETMR1713, RADNETMR1708, 443481MR, RADNETMR1720, 301279MR4, RADNETMR1696, RADNETMR1724, RADNETMR1695, 828250MRW, 704362PIO, 704384PIO, 704333PIO, 919471DDIMR, 910483CI3T, 336397P3T, 856532MR, 908735PMR, 201796MR2, 973301MR3, 732462MRPNR, RADNETMR1711, 856231MR, SDMIADPMR1, SDMINWPMR1, SDMIBDPMR2, SDMICR3TPMR1, 718596MR, 718245MR, 631CHSPNR, 631858MR, RADNETMR1702, 315792MR, 516NYCB3T1, 516NYCB3T2, RADNETMR1704, 716278P3T, 516766MR3T, 631751MR, 518926MR3T, 518880MR, 516340MR3T, 315SDMG3T, 716656P3T, RADNETMR1707, 610402MR3T, 4603875-MDF035-1-1-1, 864225MR3T, 843681BL3T, 843797ARTMR, 8435563T, 843234MR3T, 843777PL3T, 843777PIO3T, 864255MMR, 803936LMCMR2, SPORTSMED3T, 423553MRD, 972747EAMR, 361275PIONMR, 469648EOT3T, 214320DFWD3T, 214954PCDMR, 469902EFM3T, 817741ENFW, 817592ESFW, 817433PHMR1, 830HCMPMR, 972805ENFMR1, 972495TSGMR2, 713512MHMR1, MHNEMR1, 972258HAMR1, 281HMI750W, RADNETMR678, 832638SCMR1, 512APIRRMR, 210MSNWPMR, 817424TSSL3T, 801ENVBMR3, 801377MR6, 757578GE3T, 262289MR1, LXTPMSW1NET, LXTT15NET, LXTT43NET, 307733MR, MR5314AR, MR3048AR, MR6508AR, MR6802AR, MR6623AR, MR52800461, 83203735240, 83183534632, 83183547990, 83141851264, 83183543071, 83144557293, 83178104799, 834MR000002, 83183539988, 834MR000005, 834MR000006, 83132425984, 834MR000050, 834MR000021, 834MR000015, 83155846100, 834MR000013MM4, 83210367946, 83178782037, 83201375088, 83152240359, 833MR000024, 833MR000024MM4, 83199160995, 83170864668, 83153235400, 083027603871918, 083027600728323, 083027600259223, 083027600101122, 083027607448619, BY4197MR01, 190207MR01, 110009MR01, 150019MR01, 110059MR01, MRUA2341, MRUA2246, MRUA0897, MRUA0751, MRUA0592, MRUA1533, MRUA2387, MRUA1058, MRUA2091, MRUA1977, MRUA1479, MRUA0790, MRUA2067, MRUA1053A, MRUA1135, MRUA2262, MRUA2182, MRUA1761, MRUA1746, MRUA0774, MRUA1294, MRUA2012, MRUA2303, MRUA2342, MRUA1595, MRUA1721, BG4605MR01, 403253MR1, 250598MR1, MR2470CL, MRUA1674, 082427110150, 082427110108, 082427110148, 082427040339, 082427040219, 082427040202, 082427040245, 082427220133, 082427230246, 082427090424, 082427010211, 082427010142, 082427060114, 082427100458, 082427100420, 082427290066, 082427030188, 082427160345, 082427160277, 082427070336, 082427070237, 082427090336, 082427240106, 082427040260, 082427040234, 082427040211, 082427150102, 082427020100, 082427080114, 082427060086, 082427140324, 082427050050, 082427050048, 082427100387, 082427200211, 082427090368, 082427070341, 082427260011, 082427250078, 082427080090, 082427030161, 082427030184, 082427140204, 082427030154, 082427100416, 082427100419, 082427090454, 082427100357, 082427010204, 082427100422, 082427250087, 082427030193, 082427090397, 082427090346, 082427220128, 082427020095, 082427100365, 082427030147, 082427010161, 082427290065, 082427290072, 082427160194, 082427160338, 082427160306, 082427160264, 082427160395, 082427160398, 082427160363, 082427160294, 082427180086, 082427240107, 082427240075, 082427240089, 082427170033, 082427170047, 082427210168, 082427210200, 082427090369, 082427070269, 082427070328, 082427070333, 082427070334, 082427070221, 082427070326, 082427070250, 082427070291, 082427070228, 082427070192, 082427070302, 082427070259, 082427070220, 082427010206, 082427010167, 082427010213, 082427090377, 082427090374, 082427090382, 082427090360, 082427090383, 082427090340, 082427090355, 082427090332, 082427090339, 082427090353, 082427090399, 082427090348, 082427090412, 082427210206, 082427190193, 082427
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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