Reported Apr 14, 2021 · Terminated
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from 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 · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- Ysio X.pree
- Model Number11107464 -
- Product UsageA Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities
- Lot codes and dates
- Serial Numbers
100411004610055100571005310049100431003910054100481004210045
- Serial Numbers
- Amount recalled
- 12 units
Where it was sold
Why it was recalled
A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted
This product could cause temporary or reversible health problems — stop using it.
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