Z-2762-2011

syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication...

Name: Z-2762-2011 syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication...
Creator: Siemens Medical Solutions, USA, Inc
Published: 2011-05-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-05-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display... on 2011-05-10. The reason FDA records is "For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the...". 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-2762-2011
Status: Terminated
Initiated: 2011-05-10
Posted: 2011-07-08
Terminated: 2012-07-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.
Quantity in commerce: 38
Distribution: Nationwide Distribution
Product codes and lots: Serial numbers 10091602 and 10091604

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)