Health Canada — Medical Devices · Canada · 2015-01-21 · Type III
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Reported risk: Systems may experience an unintentional motion or rotation due to a positioning user interface issue. The potential reversed motion of the gantry/table has been observed when the user positions the joystick at its maximum position (end of travel) on the smart box. The unintended reversal of the direction of the motion may lead to a collision of the table or C-arm with medical instruments, patient or personnel, and result in injury.
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