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FDAFDA · Alimentos y medicamentos·N.º oficial 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

Publicado el 14 de agosto de 2024 · Inicio del retiro: 14 de junio de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Medical Systems, LLC
Distribuidor
Worldwide distribution.
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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