Z-0652-2007

Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system

Name: Z-0652-2007 Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system
Creator: Siemens Medical Solutions, USA, Inc
Published: 2007-01-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-01-31 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system on 2007-01-31. The reason FDA records is "The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect". 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-0652-2007
Status: Terminated
Initiated: 2007-01-31
Posted: 2007-03-28
Terminated: 2008-04-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
Root cause tag: software
FDA root cause: Other
Action: Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.
Quantity in commerce: 71
Distribution: Nationwide.
Product codes and lots: All units. Version 5.0

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)