—#105379

Product

syngo.plaza 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

Why it was recalled

Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution New York

Timeline

Recall initiated: 2011-09-21
Posted by FDA: 2012-01-11
Terminated: 2014-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.