Reported Apr 13, 2016 · Terminated
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate,…
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?
- A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
- Lot codes and dates
- Model # 10014063
- Amount recalled
- 49 imaging systems
Where it was sold
Why it was recalled
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
This product could cause temporary or reversible health problems — stop using it.
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