Z-0597-2016Class II

Software version VD10E for Syngo X-Workplace; Picture archiving and communication system

Name: Z-0597-2016 Software version VD10E for Syngo X-Workplace; Picture archiving and communication system
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-11-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-11-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Software version VD10E for Syngo X-Workplace; Picture archiving and communication system on 2015-11-18. FDA classified it as Class II and gives the reason as "Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted...". 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-0597-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2016-01-06
Terminated: 2016-12-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Important Customer Safety Notice dated November 17, 2015. The Notice identified the product, the problem, and the action to be taken by the customer. The potential issue will be remedied with a software update via Update Instructions AX067/15/S. Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers with questions were advised to call 800-888-7436.
Quantity in commerce: 73 units
Distribution: Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.
Product codes and lots: Software Version: SW VD-10E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0597-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

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)