Health Canada — Medical Devices · Canada · 2025-05-09 · Type II
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Reported risk: The loss of motion has been found to occur intraoperatively due to an instrument failure, causing the system to halt teleoperation with the robotic instrument. While the instrument is disabled and during the user's removal of the instrument it is possible for the user to trigger an error code by applying excessive torque which also disables the arm cart assembly (ACA). In both scenarios (disabled instrument, and disabled ACA) halting of teleoperation is an intended response of the system to prevent further use of the robotic instrument or arm cart assembly until the issue is resolved, or the portion of the system with issue is replaced. Recall Start Date: April 29, 2025
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