OEC Uroview 2800 — Class II medical device recall Z-1865-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-07-04. Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking in
| Recall number | Z-1865-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2006-11-20 |
| Classified | 2012-06-22 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2012-06-25 |
| Quantity | 717 units |
| Serial numbers | P4-0004-L, P4-0005-L, P4-0006-R-RC1, P4-0007-R-RC, P4-0008-R, P4-0011-L, P4-0012-R, P4-0013-L, P4-0014-L, P4-0015-L, P4-0016-L, P4-0017-L, P4-0018-L, P4-0019-R, P4-0020-L, P4-0021-L, P4-0022-R, P4-0023-L, P4-0024-R, P4-0025-R, P4-0026-L, P4-0027-R, P4-0028-R, P4-0029-R, P4-0030-R and 475 more |
| Model numbers | A349855 |
Product
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Reason for recall
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
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-1865-2012. 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.