Reported Apr 11, 2018 · Terminated
Syngo.via. Medical Device Software. Picture archiving and communications 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?
- Syngo.via. Medical Device Software. Picture archiving and communications system.
- Lot codes and dates
- Model Number 10496180
- Amount recalled
- 236 units
Why it was recalled
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
This product could cause temporary or reversible health problems — stop using it.
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