Official recall record
3mensio Workstation (Vascular Fenestrated) software
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-07
- Country of alert
- Netherlands
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 08056304455925
- Brand on record
- PIE Medical Imaging B.V.
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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