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…
Read the official notice →- Date
- 2025-08-20
- Country
- United States
- Brand
- PIE Medical Imaging
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Classification
- Class II
- Units
- US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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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:…
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