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.
Recall
- Recall Number
- Z-0037-2025
- Event Number
- 95194
- FEI Number
- 3023140882
- Product Code
- JAK
- Status
- Completed
- Root Cause
- Under Investigation by firm
- Initiated
- August 5, 2024
- Posted
- October 9, 2024
- Address
- QUANTUM SURGICAL SAS 1000 rue du mas de verchant ZAC Eureka montpellier France
Description
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.
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Quantum Surgical issued an URGENT FIELD SAFETY NOTICE to its sole consignee via visit on 08/05/2024 and followed up with an email on 08/19/2024. The notice explained the problem, potential risk, and requested that the consignee cease use of the device. The affected units were returned, repaired, and replaced.
US Nationwide distribution in the state of FL.
2 units