Reported May 11, 2016 · Terminated
Syngo Dynamics; Kinetdx Picture Archiving and Communications 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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Syngo Dynamics; Kinetdx Picture Archiving and Communications System
- Lot codes and dates
- Model Numbers
10091637100916731009180510091807
- Serial Numbers
84 of 84 codes
850218504085042850458504785057850798508085081850868509085115851438514585146851478514985157851678516885170851728517785178851858518685189851918523485235852398528185307853098532285325853268532985335853388535085353853548536885370853748537785380853858538785401854188542185422854278543585442854478546285467
- Model Numbers
- Amount recalled
- 84 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
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
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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