PIE Medical 3mensio Workstation software recalled for measurement accuracy errors in cardiac imaging
What this means
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.
- If you use 3mensio Workstation version 10.7, contact PIE Medical Imaging B.V. for updated software or guidance
- Review recent cardiac measurements made under the conditions described to determine if results need clinical verification
- Do not rely solely on affected software measurements for patient diagnosis or treatment planning without additional clinical assessment
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2026Want us to check the next one for you?
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