Z-2628-2016 Class II Terminated

Recalled by GE OEC Medical Systems, Inc — Salt Lake City, UT

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