Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop… — Class II medical device recall Z-0984-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-03-13, distributed nationwide. The swivel arm holding the monitors may become dislodged from the carrying arm.
| Recall number | Z-0984-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-02-08 |
| Classified | 2019-03-07 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Serial numbers | 3414, 3415, 3416, 3417, 3418, 3428 |
| Model numbers | 10094910 |
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 for recall
The swivel arm holding the monitors may become dislodged from the carrying arm.
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-0984-2019. 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.