Reported Sep 21, 2016 · Terminated
Syngo.Plaza VB 10 A, image processing 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?
- Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
- Lot codes and dates
- Model Numbers
10863171108631721086317310592457
- Serial Numbers
99 of 99 codes
100262100389100198100258100259100538100135100133100213100214100031100032100484100362100233100140100141100142100143100144100416100105100106100109100110100111100112100113100114100115100116100117100119100120100461100457100245100447100364100314100298100299100386200277100139100027100028100300100559100440100441100197100170100025100026100084100186100189100190100191
- Model Numbers
- Amount recalled
- 101 Systems
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
- Nationwide
Why it was recalled
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
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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