—#119697

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102150
Affected lot / code info: Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

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

Timeline

Recall initiated: 2013-06-10
Posted by FDA: 2013-08-01
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119697. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.