Recall Z-2767-2026 ยท QIH Automated Radiological Image Processing Software
PIE Medical Imaging B.V.
3mensio Workstation (Vascular Fenestrated) software
| Date | Jul 21, 2026 (initiated May 7, 2026) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Software change control |
| 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 retu |
| Quantity | 165 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250330 | 3mensio Workstation Pie Medical Imaging BV, Nov 3, 2025 |