Health Canada — Medical Devices · Canada · 2023-12-05 · Type II
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Reported risk: Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the vesa holder of the aCart™ compact, due to incorrect length screws used penetrating the lithium-ion battery of the device. Investigations have identified that the fire hazard was a direct consequence of a battery short-circuit, which, in turn, was triggered by the use of excessively long screws to mount the device. There is no instruction for mounting in the IFU accompanying the device. Recall Start Date: November 18, 2023
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