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PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
Recalled August 20, 2025 · FDA recall Z-2297-2025 · PIE Medical Imaging B.V
Hazard
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 · FDA Class II
Units
501
Sold at
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Description
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
3mensio Workstation (Vascular Fenestrated) software
Manufacturer(s)
PIE Medical Imaging B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →