FDA-Device2025-08-20Class II
3mensio Workstation (Vascular Fenestrated) software
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
Sold states
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Affected count
501
Manufactured in
Demertdwarsstraat 8A01, N/A, Maastricht, N/A, Netherlands
Products
3mensio Workstation (Vascular Fenestrated) software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2297-2025Don't want to check this manually?
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