PIE Medical Imaging recalls
2 official recalls and safety alerts involving PIE Medical Imaging since 2025-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with PIE Medical Imaging or the relevant agency.
- 2026-07-29
USPIE 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:…
FDA · DevicePIE Medical Imaging B.V.Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and…Official notice →- 2025-08-20
- US
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
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…
FDA · DevicePIE Medical Imaging B.V.US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA,…Official notice →