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GE Healthcare, LLC recalls Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Recalled September 19, 2012 · FDA recall Z-2255-2012 · GE Healthcare
Hazard
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. · FDA Class II
Units
254 total in the US
Sold at
Worldwide Distribution -- USA (nationwide) Distribution
Description
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Product
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →