FDA recall, , Moderate risk
3mensio Workstation (Vascular Fenestrated) Software
The software may report a measurement larger than the actual anatomical dimension.
Summary by Recall Canary from the FDA notice
What happened
PIE Medical Imaging B.V. of Maastricht, Netherlands, recalled its 3mensio Workstation (Vascular Fenestrated) software after the FDA added it to the Enforcement Report on July 21, 2026.
The recall began May 7, 2026, and affects users with access only to 3D Echo or Mitral 3D Echo who analyze Philips 3D echo datasets containing Color Doppler information, where reported measurements may be larger by 0.8% to 34.4% than actual anatomical dimensions.
The software is distributed in California, Michigan, Minnesota, New York, and Texas, and internationally in the United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, and Belgium.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
3mensio Workstation (Vascular Fenestrated) software
- UDI-DI
- 08056304455925
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, New York, Minnesota, Michigan, Texas and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium.
- Company
- PIE Medical Imaging B.V.Maastricht, Netherlands
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98930
- Recall number
- Z-2767-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
