Lower risk Medical device recall · FDA · Published May 7, 2026

PIE Medical Imaging 3mensio Workstation Software Recall: Measurement Errors in Vascular

PIE Medical Imaging recalls specific versions of 3mensio Workstation software for vascular imaging due to potential overestimation of cardiovascular measurements by up to 34.4% in certain use cases.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2767-2026Medical device PIE Medical Imaging ›

Lower-risk 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

✎ GovInfoNow plain-language explainer

PIE Medical Imaging has recalled specific versions of their 3mensio Workstation software for vascular imaging. The software may report measurements that are up to 34.4% larger than actual anatomical dimensions when used with Philips 3D echo datasets containing color Doppler information. Read more at govinfonow.com/recall/128010-pie-medical-imaging-3mensio-workstation-software-recall-measurement-errors-in.

Source Summary by GovInfoNow · govinfonow.com/recall/128010-pie-medical-imaging-3mensio-workstation-software-recall-measurement-errors-in · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2767-2026

Cite this page

“PIE Medical Imaging 3mensio Workstation Software Recall: Measurement Errors in Vascular.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/128010-pie-medical-imaging-3mensio-workstation-software-recall-measurement-errors-in. Based on FDA recall #Z-2767-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2767-2026%22&limit=1).

PIE Medical Imaging B.V. recalled 3mensio Workstation (Vascular Fenestrated) software worldwide due to potential measurement errors, according to the FDA. The Food and Drug Administration announced the Class II voluntary recall on May 7, 2026.

How to tell if you have it

Brand: PIE Medical Imaging
Product: 3mensio Workstation (Vascular Fenestrated) software
UPC: 08056304455925
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

The hazard

User measurement values reported by the diagnostic bioimaging software may be larger than actual anatomical dimensions if specific conditions are met, according to the FDA. The hazard occurs when the user has access only to 3D Echo or Mitral 3D Echo and analyzes a Philips 3D echo dataset containing Color Doppler information.

Context

GovInfoNow's records show PIE Medical Imaging B.V. has one other recall on record since July 14, 2025, for the 3mensio Workstation Software regarding vascular analysis errors. Other recent recalls of similar products include Philips EPIQ Elite Ultrasound System Recall: Inaccurate Blood Flow Measurements (August 7, 2026), Merge PACS Workstation Software Inaccurate Measurements - Recall (July 22, 2026), and Philips Ingenia 3.0T MRI Systems Recall: Stiffness Errors in MRE Imaging (December 3, 2025).

How to tell if you have this one

Check for software versions 10.7 with specific UDIs listed in the recall notice. The affected versions include SP1 through SP5 updates for the 3mensio Workstation (Vascular Fenestrated) software.

Brand
PIE Medical Imaging
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your software version against the listed UDIs in the recall notice to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 5 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Michigan, Minnesota, New York, Texas.

Recall timeline

FDA published this recall 3 months after the firm started it.

May 7, 2026Firm started the recall
Jul 21, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What versions of the software are affected?

Software versions 10.7 with specific 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.

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Link to this recall

<a href="https://govinfonow.com/recall/128010-pie-medical-imaging-3mensio-workstation-software-recall-measurement-errors-in">PIE Medical Imaging 3mensio Workstation Software Recall: Measurement Errors in Vascular (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2767-2026 (May 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2767-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.