Reported Jan 21, 2015 · Terminated
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures…
GE OEC Medical Systems, Inc.
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 OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Lot codes and dates
- GE OEC Brivo 865 Plus Serial Numbers3 B4S1403 4
B4S13011B4S13012B4S13016B4S13018B4S13020B4S13029B4S13031B4S13035B4S13038B4S13043B4S13054B4S13056B4S13059-B4S13061B4S14002-B4S14004B4S14007B4S14015B4S14016B4S14022B4S14022B4S1403
- GE OEC Brivo 865 Plus Serial Numbers
- Amount recalled
- 61 units installed in US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
This product could cause temporary or reversible health problems — stop using it.
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