Device product
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Z-1469-2017
Product summary
- Event
- Event 76568
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1469-2017
Official wording
Reason: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Code information: OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
Distribution pattern: One consignee in CA.
Derived failure modes
-
Manufacturing or process control
assembly issue