montpellier, France
QUANTUM SURGICAL SAS recalls
2 recalls recorded since 2018, most recently on 23 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 May 2025
- Reason
- Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1927-2025
- EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in ver
Completed Class II Medical devices
- Recall started
- 5 August 2024
- Reason
- Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
- Distribution
- US Nationwide distribution in the state of FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0037-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.