PIE Medical Imaging B.V.: Device Recall
Recall #Z-2297-2025 · 07/14/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2297-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- PIE Medical Imaging B.V.
- Status
- Ongoing
- Date Initiated
- 07/14/2025
- Location
- Maastricht, N/A, Netherlands
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 501
Reason for Recall
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
Product Description
3mensio Workstation (Vascular Fenestrated) software
Distribution Pattern
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.