Device product
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Z-0761-2013
Product summary
- Event
- Event 64226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units installed in US
- Official record key
device-enforcement:Z-0761-2013
Official wording
Reason: 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.
Code information: Model Number : 5271997
Distribution pattern: Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
Derived failure modes
-
Device software or design
software issue