FDA-Device2013-08-07Class II
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.
Siemens Medical Solutions USA, Inc
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
Sold states
US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
Affected count
9
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1859-2013Don't want to check this manually?
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