FDA Device recall Z-0374-2014
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified f…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified f… by Siemens Medical Solutions Usa, citing A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in ra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0374-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-03 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Reason
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
Identifiers
| code_info | Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0374-2014%22
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