Z-2767-2026Class II

3mensio Workstation (Vascular Fenestrated) software

Name: Z-2767-2026 3mensio Workstation (Vascular Fenestrated) software
Creator: PIE Medical Imaging B.V.
Published: 2026-05-07
License: https://open.fda.gov/license/

PIE Medical Imaging B.V. / initiated 2026-05-07 / Open, Classified / root cause: software

FDA source

PIE Medical Imaging B.V. began a recall of 3mensio Workstation (Vascular Fenestrated) software on 2026-05-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2767-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-07
Posted: 2026-07-21
Recalling firm: PIE Medical Imaging B.V.
Product: 3mensio Workstation (Vascular Fenestrated) software
Product code: QIH Automated Radiological Image Processing 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
Root cause tag: software
FDA root cause: Software change control
Action: On 5/7/2026, correction notices were emailed to customers who were asked to do the following: 1) Do not perform measurements on Philips 3D echo datasets containing the doppler information using 3mensio Workstation 10.7, 10.7 SP1 SP5. 2) Ensure that this notice is distributed to all relevant personnel within your organization and to any organization where the affected product may have been transferred to or is in use. 3) PMI recommends follow-up to verify if results of ordered devices are correctly analyzed/calculated. 4) Complete and return the enclosed Customer Acknowledgment Form and return via email to [email protected] This issue has been resolved in 3mensio Workstation 10.7 SP6. PMI will support users in upgrading to this version.
Quantity in commerce: 165
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.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2767-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2767-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-21

Product code QIH

K250330Class II3mensio WorkstationPie Medical Imaging BV / cleared 2025-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)