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
- Agency
- FDA Device
- Recall date
- May 7, 2026
- Status
- Ongoing
- Company
- PIE Medical Imaging B.V.
1. What product was recalled?
3mensio Workstation (Vascular Fenestrated) software
3mensio Workstation (Vascular Fenestrated) software
Quantity: 165
Code or lot text: 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
- LOT
- (01)08056304455925(11)250523(8012)10.7 SP1
- LOT
- (01)08056304455925(11)250714(8012)10.7 SP2
- LOT
- (01)08056304455925(11)250729(8012)10.7 SP3
- LOT
- (01)08056304455925(11)251016(8012)10.7 SP4
- LOT
- (01)08056304455925(11)251103(8012)10.7 SP5
- LOT
- Software Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7
- RECALL-NUMBER
- Z-2767-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- California: 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.
- Michigan: 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.
- Minnesota: 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.
- New York: 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.
- Texas: 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.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.