Recall Z-1859-2013 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
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.
| Date | Aug 1, 2013 (initiated Jun 10, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS. Update instructions were also provided. The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future. We regret any inconvenience that this may cause , and we thank you in advance f |
| Quantity | 9 |
| Distribution | US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102150 | SYNGO DYNAMICS, VERSION 9.0 Siemens Medical Solutions USA, Inc., Oct 5, 2010 |