3mensio Workstation (Vascular Fenestrated) software

FDA device recall Z-2297-2025 · posted 2025-08-12 · Open, Classified

Recall details

Recalling firm

PIE Medical Imaging B.V.

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

Action taken

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 vigilance@pie.nl Questions can be sent to the above email. Firm will reach out to all customers to provide a link for the software installation.

Root cause

Software change control

Status

Open, Classified

Product code

LLZ

Quantity affected

501

Distribution

US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.

Date initiated

2025-07-14

Date posted

2025-08-12

Location

Maastricht, Netherlands

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