Maastricht, N/A, Netherlands
PIE Medical Imaging B.V. recalls
2 recalls recorded since 2018, most recently on 7 May 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 May 2026
- 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
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2767-2026
- 3mensio Workstation (Vascular Fenestrated) software
Ongoing Class II Medical devices
- Recall started
- 14 July 2025
- Reason
- When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
- Distribution
- US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2297-2025
- 3mensio Workstation (Vascular Fenestrated) software
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.