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

3mensio workstation clock measurements may place stent graft fenestrations incorrectly

3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.

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: Risk-of-harm product: a measurement error in planning software that may place stent graft fenestrations incorrectly, with no patient harm reported.

Plain-English summary

The 3mensio Workstation (Vascular Fenestrated) software, version 10.6, UDI 08056304455505, is being recalled. The action covers 501 units.

According to the notice, when fenestrated analysis with clock measurements is started in the diagnostic bioimaging software, which is intended to measure and visualise 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 positions. The FDA classified the action as Class II. The source does not report any patient harm having occurred.

Distribution was nationwide in the United States, including Minnesota, New Jersey, Georgia, New York, Ohio, Kansas, Massachusetts, California and Texas.

Facilities should identify affected installations using the software version and UDI above and follow the instructions issued by the manufacturer.

The recalled product

Product
3mensio Workstation (Vascular Fenestrated) software
Manufacturer
PIE Medical Imaging B.V.
Category
Medical Device — Imaging analysis software
Hazard
  • software-issue
  • measurement-error
  • stent-graft-planning
  • class-ii

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