Reported Aug 21, 2013 · Terminated
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and…
GE Healthcare, 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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.
- Lot codes and dates
- Serial #
458 of 458 codes
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
- Serial #
- Amount recalled
- 458 (306 US; 152 OUS)
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
GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.
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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