—#105377

Product

syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082430
Affected lot / code info: Model number 10496279

Why it was recalled

Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory letter dated August 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistenceis in your system caused by this problem, please contact Siemens Service for support. 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 including the states of CA, IN, IA, NV, NE, NY, OH, TN and TX.

Timeline

Recall initiated: 2011-09-19
Posted by FDA: 2012-01-11
Terminated: 2014-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105377. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.