FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC UroView 2800, fluoroscopic x-ray system
- Recall number
- Z-2628-2016
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC UroView 2800, fluoroscopic x-ray system
- Status
- Terminated
- Initiated
- 2016-07-22
- Posted
- not on file
- Terminated
- 2016-12-19
- Reason
- 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
- 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
- 47 total
- Distribution
- Distribution US nationwide and Korea.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K993687"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28