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

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

3mensio Workstation (Vascular Fenestrated) software

On 5/7/2026, correction notices were emailed to customers who were asked to do the following: 1) Do not perform measurements on Philips 3D echo datasets containing the doppler information using 3mensio Workstation 10.7, 10.7 SP1 SP5. 2) Ensure that this notice is distributed to all relevant personnel within your organization and to any organization where the affected product may have been transferred to or is in use. 3) PMI recommends follow-up to verify if results of ordered devices are correctly analyzed/calculated. 4) Complete and return the enclosed Customer Acknowledgment Form and return via email to vigilance@pie.nl This issue has been resolved in 3mensio Workstation 10.7 SP6. PMI will support users in upgrading to this version.

• FDA enforcement recordOfficial FDA database entry for Z-2767-2026
• FDA 510(k) clearance · K250330The device's official FDA premarket clearance record
• FDA device classification · QIHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PIE Medical Imaging B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.