OEC 9800, fluoroscopic x-ray system
Recall
- Recall Number
- Z-2629-2016
- Event Number
- 74808
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Software design (manufacturing process)
- Initiated
- July 22, 2016
- Terminated
- December 19, 2016
- Address
- 384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862
Description
OEC 9800, fluoroscopic x-ray system
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
On July 22, 2016 GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers via mail to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.) Facility Administrator, 2.) Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Consignees instructured that local GE Healthcare Field Engineer will contact them to coordinate replacement of the affected monitor(s), and will ensure that system meets specifications.
Distribution US nationwide and Korea.
47 total