Z-1138-2008

syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical...

Name: Z-1138-2008 syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2007-12-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-12-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043 on 2007-12-06. The reason FDA records is "Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed". 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-1138-2008
Status: Terminated
Initiated: 2007-12-06
Posted: 2008-05-20
Terminated: 2010-12-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.
Quantity in commerce: 17 units
Distribution: Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.
Product codes and lots: Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.

Product code LLZ

K060992Class IISyngo US WorkplaceSiemens Medical Solutions / cleared 2006-04-28

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)