Device product
OEC 9800. MDL Numbers: D222250, D141598
Z-1059-2017
Product summary
- Event
- Event 76074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,256 total
- Official record key
device-enforcement:Z-1059-2017
Official wording
Reason: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
Code information: Manufactured from Feb 1998 to present
Distribution pattern: Worldwide including govt/VA/military and foreign consignees.
Derived failure modes
-
Unknown
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.