CLASS II Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
The Epione device v1.0.2 is a user controlled recalled
Quantum Surgical SAS is recalling The Epione device v1.0.2 is a user controlled, stereotactic accessory device intended to, distributed nationwide in the US. The recall was initiated on 5 Aug 2024 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-0037-2025
- FDA event ID
- 95194
- Recalling firm
- Quantum Surgical SAS, montpellier
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 5 Aug 2024
- FDA classified
- 9 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 5 Aug 2024 | Recall initiated by company | |
| 9 Oct 2024 | Classified by FDA | +65 days |
| 16 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Product as listed by the FDA
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Where it was distributed
US Nationwide distribution in the state of FL.
Questions about this recall
Why was it recalled?
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Which lots are affected?
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Where was it sold?
US Nationwide distribution in the state of FL.
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 Quantum Surgical SAS
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Epione Model 30-0001 Udi-di code: 03760305400031 The Epione¿ device recalled | Quantum Surgical SAS | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |