Reported Apr 6, 2022 · Ongoing
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic 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?
Ysiosystem with VC10 software versionModel Number 10281013. Radiographic system
- Lot codes and dates
- Serial Numbers
70 of 70 codes
201132307120118225232302122169231642238822119228442120923699211142219022146221262212822836221632272722135223472117422676220292289522917229202205822847228522265522708222752225422928228572220822071231302209222175211942360223018230192207622630211082291922825220542217720105229982011522104229662362523627
- Serial Numbers
- Amount recalled
- 70 Systems
Where it was sold
- Nationwide
Why it was recalled
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
This product could cause temporary or reversible health problems — stop using it.
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