3mensio Workstation (Vascular Fenestrated) software recallZ-2297-2025 · PIE Medical Imaging B.V. · initiated Jul 14, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PIE Medical Imaging B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software change control
What the company is doing
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.
Recall details
- Recall number
- Z-2297-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2025
- Posted by the FDA
- Aug 12, 2025
- Recalling firm
- PIE Medical Imaging B.V.
- Quantity
- 501
- Product code
- LLZ
- FDA submissions
- K153736
- Distribution
- US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Product description
3mensio Workstation (Vascular Fenestrated) software
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- 3mensio Workstation 10.7Pie Medical Imaging B.V. · System, Image Processing, Radiological2 recalls0 reports
- 3mensio Workstation 10.6Pie Medical Imaging B.V. · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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