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QUANTUM SURGICAL SAS

2 recalls •
🏥 Medical Devices
• Categories: Diagnostic Equipment

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 verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

Class I - Dangerous

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

May 23, 2025 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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

Aug 5, 2024 Diagnostic Equipment Nationwide View Details →