GE OEC Medical Systems, Inc: Medical Device Recall in 2016 - (Recall #: Z-2629-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

OEC 9800, fluoroscopic x-ray system

Product Classification:

Class II

Date Initiated: July 22, 2016

Date Posted: August 31, 2016

Recall Number: Z-2629-2016

Event ID: 74808

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.

Status: Terminated

Product Quantity: 47 total

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

Distribution Pattern:

Distribution US nationwide and Korea.

Voluntary or Mandated:

Voluntary: Firm initiated