Recall Z-2297-2025 ยท LLZ System, Image Processing, Radiological
PIE Medical Imaging B.V.
3mensio Workstation (Vascular Fenestrated) software
| Date | Aug 12, 2025 (initiated Jul 14, 2025) |
| Status | Open, Classified |
| Reason | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage |
| Root cause | Software change control |
| Action | On 7/14/2025, correction notices were mailed and emailed to customers who were asked to do the following: When using software version 10.6, in case you open a session state with saved clock measurements and there is a need to adjust the 12h position for the clock positions, make sure to update all individual clock measurements in the perpendicular plane by the following steps: 1. Click on the clock position. 2. Update the 12h pointer of the clock in the perpendicular viewport. 3. Perform step 1 and 2 for all clock measurements in the analysis. After updating all 12h pointers, the information s |
| Quantity | 501 |
| Distribution | US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153736 | 3mensio Workstation Pie Medical Imaging BV, May 27, 2016 |