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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo XWorkplace

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  Class 2 Device Recall Syngo XWorkplace see related information
Date Initiated by Firm November 18, 2015
Date Posted January 06, 2016
Recall Status1 Terminated 3 on December 05, 2016
Recall Number Z-0597-2016
Recall Event ID 72751
510(K)Number K143319  
Product Classification System, image processing, radiological - Product Code LLZ
Product Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Code Information Software Version: SW VD-10E
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
800-888-7436
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Siemens Medical Solutions, Inc
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