—#112847

Product

Siemens syngo.plaza radiological image processing system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612
Affected lot / code info: Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.

Why it was recalled

Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

Root cause (FDA determination)

Software design

Action the firm took

The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.

Timeline

Recall initiated: 2012-06-06
Posted by FDA: 2012-10-11
Terminated: 2013-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.