Quantum Surgical Sas FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. Matched by name to QMCO.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intClass IIMay 23, 2025Due to a software bug the robotic arm may incorrectly guide	Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by	Class IIDevices	May 23, 2025
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manuClass IIAug 5, 2024Quantum Surgical has become aware that a component (central	Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product num	Class IIDevices	Aug 5, 2024