Reported Oct 1, 2014 · Terminated
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body…
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?
- The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic
- exposures of the whole Body includingskull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients
- Lot codes and dates
- Model numbers
1028101310281163
- Model numbers
- Amount recalled
- 62
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.
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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