Reported Jul 2, 2014 · Terminated
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G
- Product UsageImage Intensified Fluoroscopic X-ray system
- Lot codes and dates
Model numbers 1009491010281013and 10281163 with software version VB10G
- Amount recalled
- 76
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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