Reported Aug 7, 2013 · Terminated
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the…
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 Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammography images.
- Lot codes and dates
- Model Number
1009163710091805with serial numbers 8516485289852968529785149851168517785051and 85278
- Model Number
- Amount recalled
- 9
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 initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
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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