# FDA recall Z-2767-2026

> **PIE Medical Imaging B.V.** · Class II · device recall initiated 2026-05-07.

## Product

3mensio Workstation (Vascular Fenestrated) software

## Reason for recall

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

## Distribution

Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium.

## Key facts

- **Recall number:** Z-2767-2026
- **Recalling firm:** PIE Medical Imaging B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-07
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maastricht, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2026

## Citation

> AI Analytics. FDA recall Z-2767-2026. Retrieved 2026-09-02 from https://api.ai-analytics.org/recall/Z-2767-2026. Source: US FDA. Licensed CC0.

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