PIE Medical Imaging B.V. recalls 3mensio Workstation

Recalling company

PIE Medical Imaging B.V.

Product

3mensio Workstation (Vascular Fenestrated) software

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 7, 2026

Reported

Jul 29, 2026

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.

Status

Ongoing

Quantity

165

Lot / codes

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

Company location

Maastricht, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-2767-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2767-2026 in the FDA Enforcement Report. Also see FDA recall press releases.