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Recall Observatory FDA recall evidence

Device product

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

Z-0597-2016

November 18, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 72751
Status
Terminated
Classification
Class II
Quantity
73 units
Official record key
device-enforcement:Z-0597-2016

Official wording

Reason: 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.

Code information: Software Version: SW VD-10E

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue