CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
3mensio Workstation (Vascular Fenestrated) recalled
PIE Medical Imaging is recalling 3mensio Workstation (Vascular Fenestrated), distributed nationwide in the US. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2297-2025
- FDA event ID
- 97307
- Recalling firm
- PIE Medical Imaging, Maastricht, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2025
- FDA classified
- 12 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 14 Jul 2025 | Recall initiated by company | |
| 12 Aug 2025 | Classified by FDA | +29 days |
| 20 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
3mensio Workstation (Vascular Fenestrated) software
Where it was distributed
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
Nationwide CaliforniaGeorgiaKansasMassachusettsMinnesotaMississippiNorth CarolinaNebraskaNew JerseyNew YorkOhioTexas
Questions about this recall
Why was it 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
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PIE Medical Imaging
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3mensio Workstation (Vascular Fenestrated) recalled | PIE Medical Imaging | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |