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Siemens Medical Solutions USA, Inc recalls syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the accep
Recalled August 7, 2013 · FDA recall Z-1859-2013 · Siemens Medical Solutions USA
Hazard
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 · FDA Class II
Units
9
Sold at
US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
Description
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
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →