Reported Aug 21, 2013 · Terminated
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological 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 · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
- Lot codes and dates
Model number 10592457serial numbers 100219100201100473. Update dated 5/13/13 included
- the following additional serial numbers
100177100504100174100181100473and 100539
- Amount recalled
- 6
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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