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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
The 3mensio Workstation software may report heart and vessel measurements that are 0.8% to 34% larger than the actual size when specific conditions are met: the software is used with access only to 3D Echo or Mitral 3D Echo features, and the analysis involves Philips 3D echo datasets that contain Color Doppler data. This could lead to incorrect clinical measurements used in patient care decisions.
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