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GE Healthcare, LLC recalls GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Recalled March 6, 2013 · FDA recall Z-0761-2013 · GE Healthcare
Hazard
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3. · FDA Class II
Units
9 units installed in US
Sold at
Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
Description
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Product
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →