Z-0544-2009

Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended...

Name: Z-0544-2009 Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended...
Creator: Siemens Medical Solutions, USA, Inc
Published: 2008-07-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-07-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended for acceptance, transfer, display, storage, archive... on 2008-07-23. The reason FDA records is "If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report". 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-0544-2009
Status: Terminated
Initiated: 2008-07-23
Posted: 2009-01-02
Terminated: 2010-10-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. 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: If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
Quantity in commerce: 306 of all products.
Distribution: Nationwide Distribution.
Product codes and lots: All units.

Product code LLZ

K053133Class IISyngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. / cleared 2005-12-05

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)