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MEDICAL DEVICE RECALLMODERATE

3mensio Vascular Fenestrated Workstation Software

3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.

What to do

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.

Recalled
Listed
Updated
Recall No.
Z-2767-2026
Agency
FDA
Firm
PIE Medical Imaging B.V.
Recall ID
98930
Status
ONGOING

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?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

3mensio Workstation (Vascular Fenestrated) software

UDI-DI
08056304455925, 08056304455925, 08056304455925, 08056304455925, 08056304455925, 08056304455925

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification