Reported May 7, 2014 · Terminated
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, 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 MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
- Lot codes and dates
- Mfg Lot or Serial # SystemIDBRUNSWICKMR
1,063 of 1,063 codes
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
FITZMR 00000302690MR3 HCIMR1805 00000299320MR2 HERITAGEMR00000302492MR4CORT450W00000304367MR6DOA450W00000296821MR2DUPONT3T00000000UA0069EAST750W00000298247MR8
LMCPMR00000298181MR9HSS75MR45000000294643MR2HSSFMR45000000293874MR4HSSGMR75000000300590MR7HSSHMR450W00000302945MR1HSSIMR450W00000289310MR5HSSMR75000000292367MR0INSIGHTMR322800000296573MR9INSIGHTMR323100000298959MR8INSIGHTMR324400000298573MR7JHN450W00000300722MR6JOI610450W00000305175MR2
PENNMEDMR 00001307FMM01V PHILLYNAVYMR00000301866MR0MAIN450W00000300493MR4MKMG450W00000290502MR4MR12903000000290636MR0MR12903400000288907MR9MR12903500000294913MR9MR12903600000296461MR7MR12903700000302192MR0MR22904000000303616MR7MR22904200000303691MR0MR22904300000303665MR4MR22904400001219FMM0GTMR22904500000000UA0150MR2290460000000UA0067AMR22904700000291185MR7MSK65MR100000291244MR2MSK65MR200000296595MR2MSK65MR300000294999MR8MSK68MR400000296228MR0MSK68MR500001301FMM04AOPTIMA0200000300296MR1ORMCMR100000297147MR1
STCHRISMR 00000301308MR3 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
¿¿¿420 of 420 codes
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
818 of 818 codes
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
- Mfg Lot or Serial # SystemID
- Amount recalled
- 1,548 units (704 US, 844 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
GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.
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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