Reported Apr 30, 2014 · Terminated
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
- Lot codes and dates
- .FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemIDBRUNSWICKMR
1,063 of 1,063 codes
00001250FMM026919684DMPMR100000301309MR1662800000000HM0426694700000305379MR0746200001018XF503B20559275000001227FMM00T201445750W00000297006MR9202476MR100000296307MR2202476MR200000297727MR0202476MR300000300562MR6202476MR400000000UA0153202966MR3TW00000305414MR5203739MR450W00000301842MR1203863MR450W00001203FMMOUJ205750MR500000298836MR8205838MR400000298249MR4205949MR450W00000301841MR3206292SR450W00000000UA0026206292SR750W00000293338MR0206CH750MR00000295024MR4207945MR75000001250FMM033207OA450WMR00000305461MR6208882MR450W00000299644MR5209225VC45000001026XF5173209225VC75000001105XF502C209SJMR00000000UA0143210617HUBMR00000300706MR9210MSMTMR00000000UA005221277MR100000301045MR1212989MR100000305990MR4212GE450W
FITZMR 00000302690MR3 HCIMR1805 00000299320MR2 HERITAGEMR00000302492MR4CORT450W00000304367MR6DOA450W00000296821MR2DUPONT3T00000000UA0069EAST750W00000298247MR8
LMCPMR00000298181MR9HSS75MR45000000294643MR2HSSFMR45000000293874MR4HSSGMR75000000300590MR7HSSHMR450W00000302945MR1HSSIMR450W00000289310MR5HSSMR75000000292367MR0INSIGHTMR322800000296573MR9INSIGHTMR323100000298959MR8INSIGHTMR324400000298573MR7JHN450W00000300722MR6JOI610450W00000305175MR2
PENNMEDMR 00001307FMM01V PHILLYNAVYMR00000301866MR0MAIN450W00000300493MR4MKMG450W00000290502MR4MR12903000000290636MR0MR12903400000288907MR9MR12903500000294913MR9MR12903600000296461MR7MR12903700000302192MR0MR22904000000303616MR7MR22904200000303691MR0MR22904300000303665MR4MR22904400001219FMM0GTMR22904500000000UA0150MR2290460000000UA0067AMR22904700000291185MR7MSK65MR100000291244MR2MSK65MR200000296595MR2MSK65MR300000294999MR8MSK68MR400000296228MR0MSK68MR500001301FMM04AOPTIMA0200000300296MR1ORMCMR100000297147MR1
STCHRISMR 00000301308MR3 STLUKESOPTMR00000299503MR3QUEEN450WMR00000298943MR2RADNETMR158800000298738MR6RADNETMR159300000299173MR5RADNETMR159400000301470MR1RADNETMR160300000000HM0278RADNETMR160400000297880MR7RADNETMR16140000000UA0011ARADNETMR162900000000UA0060RADNETMR163100000000UA0053RADNETMR163200000000UA0066RADNETMR163500000000UA0115RADNETMR1639XX00000000UA0062RADNETMR164800000000HM0593RADNETMR165000000000UA0149RADNETMR165100000000UA0158RADNETMR165200000300765MR5RADNETMR59300000000UA0046RADNETMR59700000000UA0055RADNETMR59800000000UA0065RADNETMR59900000289961MR5SINAI750MR00000303435MR2SINAI8MR450W00000303430MR3SINAI9MR450W00000300571MR7SLMVMR45000000298386MR4SMSUSS300000298114MR0SPRUCE450W00000297493MR9
¿¿¿ 306344MR1 00000000HM0694 403777MR1 00000000HM0701 403777MR2 00000000HM0726 905522MR2,418 of 418 codes
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
0809 of 809 codes
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
- .FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemID
- Amount recalled
- 1,546 (704 US, 842 OUS).
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize
This product could cause temporary or reversible health problems — stop using it.
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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