Recall Z-0597-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
| Date | Jan 6, 2016 (initiated Nov 18, 2015) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143319 | Syngo X-workplace SW VD10 Siemens Medi Cal Solutions, Inc., Feb 24, 2015 |