Medical Device Recall: 3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging B.V. · July 14, 2025
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
Distribution
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
States Affected
NATIONWIDE
Quantity Affected
501
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2297-2025
Status: ongoing
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