Health Canada — Medical Devices · Canada · 2024-05-06 · Type II
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Reported risk: Philips has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system. The component's structural integrity may become compromised, resulting in potential contact with other gantry components located within the Incisive CT during rotation. Other components could be damaged due to the contact with the detached component. If this issue occurs, a loud noise will be emitted and the system will shut down. The cover may become displaced if the following sequence occurs: damaged component(s) come loose the damaged component(s) contact other components in the system and cause them to break a broken component makes contact with the top right gantry cover The displaced cover could create a small gap allowing a fragment of a damaged component to be expelled at a low velocity. The maximum weight of a fragment that could be expelled is 60g (2.12 ounces). Recall start date: April 18, 2024
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