Reported Mar 25, 2020 · Terminated
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Ysio, model no. 10281013
- Product UsageThe product is a stationary X-Ray system
- Lot codes and dates
- Serial Nos.
81 of 81 codes
201132003421100210862111321088211032122121223212242108520045200932011021066210312113921006201552111221122211852008820089201062010721052210892121320167210982117421057211012111621117211182112021091210922103721076210772120021203212092014921163211722117121173200942111520047211942019321211212122118621188
- Serial Nos.
- Amount recalled
- 81 US/ 308 worldwide
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.
This product could cause temporary or reversible health problems — stop using it.
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