3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
Contact your local PIE Medical Imaging representative or the company's technical support team for guidance on software updates or mitigation steps to ensure measurement accuracy.
Why it was recalled
PIE Medical Imaging is recalling 3mensio Workstation (Vascular Fenestrated) software because it may report cardiovascular measurements that are 0.8% to 34.4% larger than actual anatomical dimensions. This error occurs when analyzing Philips 3D echo datasets containing Color Doppler information while using only the 3D Echo or Mitral 3D Echo modules.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
3mensio Workstation (Vascular Fenestrated) software
Official source
Editorial summary by Recall Canary · last updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification