Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3mensio Workstation (Vascular Fenestrated) software Recalled by PIE Medical Imaging B.V. Due to When fenestrated analysis with clock measurements is started...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PIE Medical Imaging B.V. directly.
Affected Products
3mensio Workstation (Vascular Fenestrated) software
Quantity: 501
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PIE Medical Imaging B.V.
PIE Medical Imaging B.V. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report