PIE Medical Imaging B.V.: Medical Device Recall in 2025 - (Recall #: Z-2297-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

3mensio Workstation (Vascular Fenestrated) software

Product Classification:

Class II

Date Initiated: July 14, 2025

Date Posted: August 20, 2025

Recall Number: Z-2297-2025

Event ID: 97307

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

Status: Ongoing

Product Quantity: 501

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated