Health Canada — Medical Devices · Canada · 2020-04-15 · Type II
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Reported risk: Philips has identified that no torque was specified for the four screws that connect the gearbox and the mounting flange within the c-arm roll motor. If the torque is too low, the movement of the system may lead to stress on the screws, which potentially could result in the four screws becoming loose. If this occurs, the c-arm could rotate freely over the "roll" movement and the system would not be available for use.
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