Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
FDA Recall Z-0174-2010 · Posted 2009-11-10
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-09-30
Date Terminated2012-07-05
Product Quantity2 units
Reason for Recall
Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.
Firm Action
The recalling firm issued a "Customer Safety Advisory Notice" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center.
Root Cause
Software design
Distribution Pattern
The product was shipped to medical facilities in NY and OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.