Recall Z-2767-2026— PIE Medical Imaging B.V.
Class II · Ongoing
Class II FDA medical device recall by PIE Medical Imaging B.V., initiated 2026-05-07. It names one FDA 510(k) clearance: K250330. Product: 3mensio Workstation (Vascular Fenestrated) software. 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.
- Recalling firm
- PIE Medical Imaging B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-07
- Firm location
- Maastricht, N/A, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3mensio Workstation (Vascular Fenestrated) software
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.