Z-1038-2008

Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version...

Name: Z-1038-2008 Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-12-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-12-21 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA... on 2007-12-21. The reason FDA records is "Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system". 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-1038-2008
Status: Terminated
Initiated: 2007-12-21
Posted: 2008-04-29
Terminated: 2008-09-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.
Quantity in commerce: 47 Units
Distribution: Nationwide Distribution.
Product codes and lots: Model Number: 7129534. Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641. Software version VB30B.

Product code LLZ

K040970Class IILeonardoSiemens Medical Systems, Inc. / cleared 2004-07-08

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)