Z-2629-2016Class II

OEC 9800, fluoroscopic x-ray system

Name: Z-2629-2016 OEC 9800, fluoroscopic x-ray system
Creator: GE OEC Medical Systems, Inc
Published: 2016-07-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-07-22 / Terminated / root cause: software

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 9800, fluoroscopic x-ray system on 2016-07-22. FDA classified it as Class II and gives the reason as "A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2629-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-22
Posted: 2016-08-23
Terminated: 2016-12-19
Recalling firm: GE Healthcare
Product: OEC 9800, fluoroscopic x-ray system
Product code: OWB Interventional 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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: On July 22, 2016 GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers via mail to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.) Facility Administrator, 2.) Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Consignees instructured that local GE Healthcare Field Engineer will contact them to coordinate replacement of the affected monitor(s), and will ensure that system meets specifications.
Quantity in commerce: 47 total
Distribution: Distribution US nationwide and Korea.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2629-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2628-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2629-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)