Z-1089-03

Leonardo Workstations with software versions prior to 2022A

Name: Z-1089-03 Leonardo Workstations with software versions prior to 2022A
Creator: Siemens Medical Solutions USA, Inc
Published: 2003-02-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-02-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Leonardo Workstations with software versions prior to 2022A on 2003-02-28. The reason FDA records is "software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment". 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-1089-03
Status: Terminated
Initiated: 2003-02-28
Posted: 2003-08-07
Terminated: 2004-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Leonardo Workstations with software versions prior to 2022A
Product code: LLZ System, Image Processing, Radiological
Reason for recall: software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
Quantity in commerce: 1374 units
Distribution: The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
Product codes and lots: Model 7129534 Serial #01001 through 01380, 05001 through 05600, and 10001 through 10320

Product code LLZ

K010938Class IISyngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. / cleared 2001-06-26

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)