Z-2297-2025Class II

3mensio Workstation (Vascular Fenestrated) software

Name: Z-2297-2025 3mensio Workstation (Vascular Fenestrated) software
Creator: PIE Medical Imaging B.V.
Published: 2025-07-14
License: https://open.fda.gov/license/

PIE Medical Imaging B.V. / initiated 2025-07-14 / Open, Classified / root cause: software

FDA source

PIE Medical Imaging B.V. began a recall of 3mensio Workstation (Vascular Fenestrated) software on 2025-07-14. FDA classified it as Class II and gives the reason as "When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock...". 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-2297-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-14
Posted: 2025-08-12
Recalling firm: PIE Medical Imaging B.V.
Product: 3mensio Workstation (Vascular Fenestrated) software
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
Root cause tag: software
FDA root cause: Software change control
Action: On 7/14/2025, correction notices were mailed and emailed to customers who were asked to do the following: When using software version 10.6, in case you open a session state with saved clock measurements and there is a need to adjust the 12h position for the clock positions, make sure to update all individual clock measurements in the perpendicular plane by the following steps: 1. Click on the clock position. 2. Update the 12h pointer of the clock in the perpendicular viewport. 3. Perform step 1 and 2 for all clock measurements in the analysis. After updating all 12h pointers, the information shown in the fenestration diagram is correct and functionality is restored. - Pass and post this notice for all who need to be aware within your organization or to any organization where the potentially affected product is in use. - Complete and return the Customer Acknowledgement Form via email to [email protected] Questions can be sent to the above email. Firm will reach out to all customers to provide a link for the software installation.
Quantity in commerce: 501
Distribution: US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Product codes and lots: Software Version/UDI/Software Release Date: 10.6/(01)08056304455505(11)240325(8012)10.6/05-Apr-24, 10.7/(01)08056304455925(11)250423(8012)10.7/29-Apr-25, Service Packs/UDI: 10.6 SP1/(01)08056304455505(11)240411(8012)10.6 SP1/23-Apr-24, 10.6 SP2/(01)08056304455505(11)240610(8012)10.6 SP2/17-Jun-24, 10.6 SP3/(01)08056304455505(11)240926(8012)10.6 SP3/03-Oct-24, 10.6 SP4/(01)08056304455505(11)250109(8012)10.6 SP4/20-Jan-25, 10.7 SP1/(01)08056304455925(11)250523(8012)10.7 SP1/28-May-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2297-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2297-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12

Product code LLZ

K153736Class II3mensio WorkstationPie Medical Imaging BV / cleared 2016-05-27

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)