Reported Feb 25, 2015 · Terminated
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery…
GE Healthcare
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- This correction applies to all GE Healthcare MRI
- systems with superconducting magnetsDiscovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w
- Product UsageMagnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use
- Lot codes and dates
- Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 108.70972E+21
84 of 84 codes
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
8.70972E+13 609395MR 518347MR SUTTERLSMR63 of 63 codes
706774MRI412648MR1412784MR1317630HDMR610902HD1MSK55MR1317630MR1LONGWOOD15MR330535MR2859226MR208367LX1200000014890G0891027205200000264618MR0M401603600000015059GQ9SA1014MR0200000264740MR2AZ1003MR0100000262798MR2KW1013MR0200000274935MR6SY2037MR01352344MRALLIANCESIG437409838HDCMR1INSIGHTMR2025954587MR1210590NEHDMR940220MR100000015200GQ9SD1063MR0100000276248MR227003MRS0100000013471GQ885627003700000013391GQ824527633818MRI00000290734MR3277176800000014972GQ4A539530400000282503MR2LV4038MR0100000267807MR6DZ1057MR0100000273006MR72624537EXCITE00000014505GQ2IR1288MR0200000013604GQ4KW1018MR0100000272427MR6SI4024MR0100000276153MR43882676145MRMET00000280627MR13882676151MRCTRAM11ZVXTLW7210351HDMR
SUTTERDELTAMR239 of 239 codes
804270HDMR804CHESMR702731MR3407CDIMR412856MR469461BNPMR1205877MR3936568HDX209SUTAMDMR330363MR973661MR740588MR916KMMR732548MR973754MR606833MR770844NFMR530WOODMR502955JSMR512795HDMR859263MRALLIANCESIG429805PIMR1303837MRI508746JMR2352WATOUT432520MR719524MR760323MR830643MMR2937558MR805LRMR1317582MR1513870MR916KEGMR716859MR1716878MR1252209RCMR386FHDMR252OBXMR330334MR407CFRMR920451ASMHD1615451MR1818409MR1317865CWHMR806GRACEMR812485MR2812537MR775RENT1972487BGMR2972875LPMR1330945MR407303FEMR2804BSIMR540994MR323441MR2323441MR3512528CPMR1918461HD
KAISERVJOMR1,873 of 1,873 codes
937278MR704984SHD518583MR951677MR2937439MR804APMXMR706651MR256ALOPMR972599VILMR1845871MR601485MR2208265BMR904399MR2661PMCMR480612MR1518584SSMR518782LMR901226MR3910343NHMR520547MR281KELSEYMR1713442KSMR2713799TMR3765349MR1607432MR219736SLMR2631686MR276228MR863RMCMR1608364MR1704355LCHMR334347MR281599MR850325CMR1805737MR303794MR303762MR518483MR806UMCHDMR623234MR100000014328GQ9265525600000014418GQ8265793200000014497GQ2267066600000015586GQ15338MR15T516579MR1405307NMR405742SMR614898MR949721MR1309655MRI1A541382SCMR858939MR2817472MCAMR1504447MR15818713MR1203325MR4
FRYECAREMRSMSGML2SMSSWL1SMSESL1SMSVSL1SMSHML1313745DMCMR805739MR2717267MR2SMSFFI2INSIGHTMR1325SMGMR25SMSPDX1SMGMR24ALLIANCESIG424ALLIANCESIG422ALLIANCESIG423ALLIANCESIG425ALLIANCESIG426ALLIANCESIG427ALLIANCESIG428DMSIMR135ALLIANCESIG430ALLIANCESIG431ALLIANCESIG432ALLIANCESIG433SMSSVL1SMSTML1SHIMR566985BMCMRSMSUSS1SMSOSL2SMSOSL3SMGCT25250492MOBMR306766MR2601933MR1816861VAMR561863MR100000107167MR9109000000190316MR0116749100000012444GQ6116725000000015567GQ1122119800000278290MR2113450700000013737GQ2PASSMR1000007-0530-1108302759200249000000277952MR8D5195610570253MR1
CURTMRTEST104 of 104 codes
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
183 of 183 codes
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
- Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10
- Amount recalled
- 12,968 (5,708 US, 7,260 OUS).
Where it was sold
Why it was recalled
Stop using this product now
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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