Z-0647-2009

CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model...

Name: Z-0647-2009 CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-11-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-11-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications... on 2008-11-13. The reason FDA records is "Indicated orientation does not match actual orientation of the patient". 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-0647-2009
Status: Terminated
Initiated: 2008-11-13
Posted: 2009-01-08
Terminated: 2013-03-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Indicated orientation does not match actual orientation of the patient.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.
Quantity in commerce: 374 units
Distribution: Nationwide Distribution
Product codes and lots: Software versions: syngo MMW 2007C, syngo MMWP 2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT 2008G.

Product code LLZ

K052775Class IISyngo Multimodality Workplace (Syngo Mm Wp)Siemens AG Medical Solutions / cleared 2005-10-31

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)