FDA Device recall Z-2292-2014
Siemens Luminos dRF, Ysio or Uroskop Omnia systems
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of Siemens Luminos dRF, Ysio or Uroskop Omnia systems by Siemens Medical Solutions Usa, citing it was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a hig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2292-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-07 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Reason
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
Identifiers
| code_info | model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers |
|---|
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-2292-2014%22
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