FDA Device recall Z-0016-2014
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ra…
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ra… by Siemens Medical Solutions Usa, citing siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0016-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-06 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Reason
Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
Identifiers
| code_info | Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with seria…Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114. |
|---|
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-0016-2014%22
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