Reported Mar 18, 2015 · Terminated
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Lot codes and dates
- Mfg Lot or Serial # System ID
384 of 384 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 192 (131 US, 61 OUS).
Where it was sold
Why it was recalled
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
This product could cause temporary or reversible health problems — stop using it.
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