Brand
QUANTUM SURGICAL SAS
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for QUANTUM SURGICAL SAS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-18FDA-DeviceClass IIEPIONE 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 diamet
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- 2024-10-16FDA-DeviceClass IIThe 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
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
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