FDA Medical Device Recalls (openFDA)
PIE Medical Imaging B.V.: 3mensio Workstation (Vascular Fenestrated) software
- Recall number
- Z-2297-2025
- Recalling firm
- PIE Medical Imaging B.V.
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Status
- Open, Classified
- Initiated
- 2025-07-14
- Posted
- 2025-08-12
- Terminated
- not on file
- Reason
- 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
- 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 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.
- Quantity
- 501
- Distribution
- US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K153736"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003595527
- Firm city
- Maastricht
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28