Reported Oct 31, 2018 · Terminated
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
GE Medical Systems, 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 Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
GE HealthcareDiscovery 3.0T MR7505148810-25373011-25499460-2
- Lot codes and dates
- Mfg Lot or Serial # System ID8.3027E+13
339 of 339 codes
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
N/A 82427060055 N/A 82427160149 N/A 82427120135 N/A 82427160127 N/A 82427010087 N/A 82427130076 N/A 82427010094 N/A 82427030100 N/A 82427040150 N/A 82427040151 N/A 82427040172 N/A 82427070137 N/A 82427090241 N/A 82427100223 N/A 82427100225 N/A 82427100235 N/A 82427100241 N/A 82427110051 N/A 82427110058 N/A 82427120131 N/A 82427120133 N/A 82427180028 N/A 82427130075 N/A 82427140113 N/A 82427020059 N/A 82427160136 N/A 82427210130 N/A 82427210136 N/A 82427220040299 of 299 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 356 (98 US; 258 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
This product could cause temporary or reversible health problems — stop using it.
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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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