FDA Device recall Z-0805-2021
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications…
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications… by Siemens Medical Solutions Usa, citing after the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used int….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0805-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-09 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Reason
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Identifiers
| code_info | Serial Nos. 3417 3414 3415 3418 3428 3416 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2021%22
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