3mensio Workstation (Vascular Fenestrated) software
FDA Recall Z-2767-2026 · Posted 2026-07-21
Recalling FirmPIE Medical Imaging B.V.
Recall StatusOpen, Classified
Product CodeQIH
Date Initiated2026-05-07
Product Quantity165
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
Firm Action
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 [email protected]
This issue has been resolved in 3mensio Workstation 10.7 SP6. PMI will support users in upgrading to this version.
Root Cause
Software change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.