—#142124

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143319
Affected lot / code info: Software Version: SW VD-10E

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-11-18
Posted by FDA: 2016-01-06
Terminated: 2016-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.