The Recall Desk
Severity pendingFDA (Devices)·Z-2767-2026·Announced 2026-07-29

3mensio Workstation (Vascular Fenestrated) software

Pending LLM rewrite. Source: FDA_DEVICE Z-2767-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
3mensio Workstation (Vascular Fenestrated) software
Manufacturer
PIE Medical Imaging B.V.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Software Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7
  • (01)08056304455925(11)250523(8012)10.7 SP1
  • (01)08056304455925(11)250714(8012)10.7 SP2
  • (01)08056304455925(11)250729(8012)10.7 SP3
  • (01)08056304455925(11)251016(8012)10.7 SP4
  • (01)08056304455925(11)251103(8012)10.7 SP5

Distribution

Distributed nationwide across the United States.

Related recalls

Same category