syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptanc
FDA device recall Z-1859-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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
- Action taken
- 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 for your understanding. For further questions please call (610) 219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 9
- Distribution
- US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
- Date initiated
- 2013-06-10
- Date posted
- 2013-08-01
- Date terminated
- 2015-02-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 9.0 (K102150) | Siemens Medical Solutions USA, Inc. | 2010-10-05 |