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Recall Observatory FDA recall evidence

Device product

OEC 9800, fluoroscopic x-ray system

Z-2629-2016

July 22, 2016

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 74808
Status
Terminated
Classification
Class II
Quantity
47 total
Official record key
device-enforcement:Z-2629-2016

Official wording

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 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware issue