Recall database

Automated Radiological Image Processing Software recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class IIOngoingZ-2767-2026

PIE Medical Imaging B.V. recalls 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: af…

Automated Radiological Image Processing Software
Software change control

PIE Medical Imaging B.…Jul 29, 2026