Z-2628-2016 Class II Terminated
FDA device recall Z-2628-2016 was initiated by GE OEC Medical Systems, Inc on July 22, 2016 and is designated Class II. Reason for recall: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. The recall status is terminated (terminated December 19, 2016). Affected quantity: 47 total.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- July 22, 2016
- Termination Date
- December 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 total
Product Description
OEC UroView 2800, fluoroscopic x-ray system
Reason for Recall
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
Distribution Pattern
Distribution US nationwide and Korea.
Code Information
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