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Recall Observatory FDA recall evidence

Device 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.

Z-1859-2013

June 10, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65603
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1859-2013

Official wording

Reason: 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

Code information: Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.

Distribution pattern: US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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