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:…
Read the official notice →- Date
- 2026-07-29
- Country
- United States
- Brand
- PIE Medical Imaging
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More PIE Medical Imaging recalls
- 2025-08-20
USPIE 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 →
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