Reported Feb 17, 2016 · Terminated
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic…
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
- Lot codes and dates
- Lot or serial numbers include
- but not limited to
693 of 693 codes
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
- Amount recalled
- 895
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
This product could cause temporary or reversible health problems — stop using it.
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