—#85877

Product

Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license

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 7502029 - serial number 14086 and Model number 10496279 - serial number 1418

Why it was recalled

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 However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: The product was shipped to medical facilities in NY and OH

Timeline

Recall initiated: 2009-09-30
Posted by FDA: 2009-11-10
Terminated: 2012-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85877. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.