FDA Device recall Z-0984-2019
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily…
- FDA Device
- Class II
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily… by Siemens Medical Solutions Usa, citing the swivel arm holding the monitors may become dislodged from the carrying arm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0984-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-08 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Reason
The swivel arm holding the monitors may become dislodged from the carrying arm.
Identifiers
| code_info | Serial Numbers: 3414 3415 3416 3417 3418 3428 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.