Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0515-2012

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

Siemens Medical Solutions USA, Inc. / initiated 2011-09-19 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0515-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system
Product code
LLZ System, Image Processing, Radiological
Reason for recall
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 tag
software
FDA root cause
Software design
Action
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.
Quantity in commerce
12
Distribution
Nationwide Distribution including the states of CA, IN, IA, NV, NE, NY, OH, TN and TX.
Product codes and lots
Model number 10496279