3mensio Workstation (Vascular Fenestrated) software: recall status

Notice names this product. PIE Medical Imaging B.V’s 3mensio Workstation (Vascular Fenestrated) software is named in FDA Class II recall Z-2767-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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 Identifying details: 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. Units affected: 165. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: 3mensio Workstation (Vascular Fenestrated) software
Company / brand: PIE Medical Imaging B.V
Lot / serial / date 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
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.

Agency product description and boundaries

3mensio Workstation (Vascular Fenestrated) software

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: PIE Medical Imaging B.V

Recalls naming this model

FDA Class II · Medical device · July 29, 2026

3mensio Workstation (Vascular Fenestrated) software recall — PIE Medical Imaging B.V.

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 d…

Company / brand: PIE Medical Imaging B.V

Affected product: 3mensio Workstation (Vascular Fenestrated) software

Official ID Z-2767-2026 · Official record ↗

See all PIE Medical Imaging B.V recalls →

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.