Device product
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Z-0597-2016
Product summary
- 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
software issue