Z-0174-2010

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

Name: Z-0174-2010 Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-09-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-09-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license on 2009-09-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0174-2010
Status: Terminated
Initiated: 2009-09-30
Posted: 2009-11-10
Terminated: 2012-07-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
Product code: LLZ System, Image Processing, Radiological
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 However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 2 units
Distribution: The product was shipped to medical facilities in NY and OH
Product codes and lots: Model number 7502029 - serial number 14086 and Model number 10496279 - serial number 1418

Product code LLZ

K082430Class IISyngo Imaging XsSiemens AG Medical Solutions / cleared 2008-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)