Recall Atlas

Quantum Surgical recalls

2 official recalls and safety alerts involving Quantum Surgical since 2024-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Quantum Surgical or the relevant agency.

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

    QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the…

    Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

    FDA · DeviceQUANTUM SURGICAL SASWorldwide distribution - U.S. Nationwide distribution in the states of FL,IL,…Official notice →
  3. 2024-10-16
  4. US
    Drugs & medicalClass II

    QUANTUM SURGICAL SAS recalls The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of…

    Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

    FDA · DeviceQUANTUM SURGICAL SASUS Nationwide distribution in the state of FL.Official notice →