Medical Device Recall: 3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging B.V. · May 7, 2026
Reason for Recall
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Distribution
Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium.
States Affected
NATIONWIDE
Quantity Affected
165
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2767-2026
Status: ongoing
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