Home / Recalls / Medical Devices
GE Healthcare, LLC recalls GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Recalled November 28, 2012 · FDA recall Z-0200-2013 · GE Healthcare
Hazard
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. · FDA Class II
Units
364 total units installed in US
Sold at
Nationwide Distribution
Description
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Product
GE Healthcare Brivo XR 285 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 →