Reported May 21, 2014 · Terminated
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer,…
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?
- Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
- Lot codes and dates
- model numbers
10091805100918061009180710091673
- with serial numbers
8517085250851888519185198851518516585241851308516385019852878529885202851688506885206852808523585195851948512385199853648528285275851158506285067850808521685218851778524285248852378528485329852598527985230851928527785278851788522085157851148526885134
- model numbers
- Amount recalled
- 50
Where it was sold
Why it was recalled
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
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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