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PIE Medical Imaging B.V Recalls
2 recalls on record · August 20, 2025 to July 29, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
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
August 20, 2025Medical DevicesFDA
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
Hazard: 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