PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software

Recall date

July 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2297-2025

FDA classification

Class II

Brand / firm

PIE Medical Imaging B.V.

Sold / distributed

US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

3mensio Workstation (Vascular Fenestrated) software