3mensio Workstation (Vascular Fenestrated) software recallZ-2767-2026 · PIE Medical Imaging B.V. · initiated May 7, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PIE Medical Imaging B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software change control
What the company is doing
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.
Recall details
- Recall number
- Z-2767-2026
- Status
- Open, Classified
- Initiated by the company
- May 7, 2026
- Posted by the FDA
- Jul 21, 2026
- Recalling firm
- PIE Medical Imaging B.V.
- Quantity
- 165
- Product code
- QIH
- FDA submissions
- K250330
- 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.
Product description
3mensio Workstation (Vascular Fenestrated) software
Code information (models, lots, serial numbers)
Software Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7, (01)08056304455925(11)250523(8012)10.7 SP1, (01)08056304455925(11)250714(8012)10.7 SP2, (01)08056304455925(11)250729(8012)10.7 SP3, (01)08056304455925(11)251016(8012)10.7 SP4, (01)08056304455925(11)251103(8012)10.7 SP5
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 3mensio Workstation 10.7Pie Medical Imaging B.V. · System, Image Processing, Radiological2 recalls0 reports
Other devices under the same FDA submission
1 device cleared under K250330 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 3mensio Workstation 10.6Pie Medical Imaging B.V. · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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