Z-1266-2009

syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and...

Name: Z-1266-2009 syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-02-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-02-09 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS... on 2009-02-09. The reason FDA records is "An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via...". 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-1266-2009
Status: Terminated
Initiated: 2009-02-09
Posted: 2009-04-28
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).
Root cause tag: software
FDA root cause: Software design
Action: A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.
Product codes and lots: Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056.

Product code LLZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)