QUANTUM SURGICAL SAS: 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

Hazard

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

Details from the source

Reason for recall: 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. Quantity: 4 units in U.S. Lot/code info: Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001

UPC codes

03760305400031

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.