FDAClass II · Medical device · Recall Z-2767-2026 · Recalled July 29, 2026

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

Agency report date: July 29, 2026.

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.

2. Agency hazard and consumer action

FDA reports: 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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: 3mensio Workstation (Vascular Fenestrated) software

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2767-2026
Brand: PIE Medical Imaging B.V
Classification: Class II
Units affected: 165
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

3mensio Workstation (Vascular Fenestrated) software

Companies & origin

Recalling firm location: Maastricht, N/A, Netherlands
Firm address: Demertdwarsstraat 8A01, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Firm notified the public via: N/A
FDA event ID: 98930
Recall initiated: May 7, 2026
FDA classified: July 21, 2026
FDA report date: July 29, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

Report a data error on this page