The Recall Desk
HighFDA (Devices)·Z-2297-2025·Announced 2025-08-20

[pending] 3mensio Workstation (Vascular Fenestrated) software

Pending LLM rewrite. Source: FDA_DEVICE Z-2297-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
3mensio Workstation (Vascular Fenestrated) software
Manufacturer
PIE Medical Imaging B.V.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category