FDA Enforcement
Class II
Terminated
OEC UroView 2800, fluoroscopic x-ray system
Recall: Z-2628-2016
·
Reported August 31, 2016
Enforcement
- Recall Number
- Z-2628-2016
- Event ID
- 74808
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE OEC Medical Systems, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 31, 2016
- Initiation Date
- July 22, 2016
- Classification Date
- August 23, 2016
- Termination Date
- December 19, 2016
- Address
- 384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States
Description
OEC UroView 2800, fluoroscopic x-ray system
Reason
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
Code Info
monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347
Distribution
Distribution US nationwide and Korea.
Quantity
47 total