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PIE Medical Imaging
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for PIE Medical Imaging and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-29FDA-DeviceClass IIPIE Medical 3mensio software recalled for cardiac measurement errors
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
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