Siemens RAD Fluoro Uro Systems — Class II medical device recall Z-0016-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-11-13, distributed nationwide. Siemens has discovered through product monitoring a potential malfunction when using system operating with sof
| Recall number | Z-0016-2014 |
|---|---|
| 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 | 2013-05-06 |
| Classified | 2013-11-01 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 23 |
| Reason classes | device malfunction, software |
| Serial numbers | 1025, 1032, 1035, 1036, 1040, 1041, 1045, 1047, 21089, 21098, 21163, 21167, 21171, 21186, 21187, 21188, 21189, 21194, 21212, 21213, 21221, 21223, 31114 |
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 for recall
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
Machine access
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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.