Reported Oct 31, 2018 · Terminated
GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex…
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 Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
- Lot codes and dates
- Mfg Lot or Serial # System IDMISSING_SN_GON4217108 408358SHMR13 Missing_SN_GON4227287
104 of 104 codes
00000001140049BMDACCMR100000001140050BMDACCMR10000011-4-0050BMDACCMR10000011-4-0009920568MR3T0000011-4-0015920568MR3T0000011-4-0017602406IMR0000011-4-0018602406IMR0000011-4-0024602406IMR0000014-4-0007602406IMR0000011-4-0028626359MR30000011-4-0032626359MR30000011-4-0046MSK68MR40000011-4-0047MSK68MR40000028-3-0011MSK68MR40000044-4-0046MSK68MR40000011-4-0064415CB3TW0000011-4-0065415CB3TW0000011-4-0066415723SHAW120000011-4-0067415723SHAW120000011-4-0075616267IMRI0000011-4-0076616267IMRI011-4-0085616267IMRI011-4-0170616267IMRI0000011-4-0094330344MR750W011-4-0118330344MR750W0000011-4-0101713792CMR10000011-4-0102713792CMR10000011-4-0107317887MR30000011-4-0108317887MR30000011-4-0114309655MR750W
73 of 73 codes
309655IMRI0000011-4-0019416369MR3T0000011-4-0020416369MR3T011-4-0128E416249MR211-4-0127E416249MR20000011-4-00270824270401010000011-4-00330824270401010000011-4-01330824270401670000011-4-01340824270401670000011-4-0086CS1006MR030000011-4-0092CS1006MR030000011-4-0153CS1006MR030000011-4-0158A55474220000011-4-0159A55474220000011-4-0103EM02290000011-4-0104EM02290000011-4-0156EM02760000011-4-0157EM02760000011-4-0165EM02760000011-4-0166EM02760000028-4-0016RTD01910000011-4-0060RTD01910000011-4-0061RTD01910000011-4-009309202790240000011-4-009809202790240000011-4-0034PER086260000011-4-0035PER086260000011-4-0056RO1098MR020000011-4-0057RO1098MR020000011-4-0030ZA2169MR010000011-4-0031
- Mfg Lot or Serial # System ID
- Amount recalled
- 90 (54 US; 36 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
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.
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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