Reported Jul 6, 2016 · Terminated
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography…
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 Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
- Lot codes and dates
- Device Model # 10496180
- Serial Numbers
221176130159130773100641100642100643100644100645100811100812100813100814221129130326221192130201220930130438102113130635130377130125130546130322101309101503220743102013130575
- Amount recalled
- 29 units
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
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
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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