Recall Z-2297-2025— PIE Medical Imaging B.V.
Class II · Ongoing
Class II FDA medical device recall by PIE Medical Imaging B.V., initiated 2025-07-14. It names one FDA 510(k) clearance: K153736. Product: 3mensio Workstation (Vascular Fenestrated) software. 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.
- Recalling firm
- PIE Medical Imaging B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-14
- Firm location
- Maastricht, N/A, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3mensio Workstation (Vascular Fenestrated) software
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.