Z-1232-2016Class II

syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization...

Name: Z-1232-2016 syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data... on 2016-02-24. FDA classified it as Class II and gives the reason as "After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure". 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-1232-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-03-23
Terminated: 2017-02-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
Product code: LLZ System, Image Processing, Radiological
Reason for recall: After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Important Customer Safety Notice dated February 24, 2016, to all affected customers notifying them that the issue will be remedied with a software update via AX004/16/S. Following the installation of this update, the segmentation results can be used at the CARTO system as described in the operator manual. Customers with questions were instructed to call 800-888-7436. For questions regarding this recall call 610-448-6461.
Quantity in commerce: 6
Distribution: Nationwide Distribution to IL, NY, MT, and MN.
Product codes and lots: Serial # 20119, 20098, 20041, 20124, 12177, 20026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1232-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-23

Product code LLZ

K143319Class IISyngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc. / cleared 2015-02-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)