OEC UroView 2800 — Class II medical device recall Z-2628-2016
Terminated recall by GE OEC Medical Systems, Inc, reported 2016-08-31, distributed nationwide. A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appe
| Recall number | Z-2628-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2016-07-22 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2016-12-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 47 total |
| Reason classes | software |
| Model numbers | 5448359-01, 5459219-01, 82-0420, 82-0576, 82-0596, 82-0700, 82-0794, 82-0986, 82-1182, 82-1504, 82-1515, 82-1593, 82-1998, 82-2335, 82-3256, 82-3258, 82-3494, 82-3748, 82-3925, 82-7101-MH, 89-0416, 89-0711, 89-0846, 89-1323, 89-1363 and 23 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2628-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.