Safety Alerts

Medical device manufacturer, Philips Healthcare., has issued a medical device safety alert concerning its Incisive CT/CT 3500/CT 5300 System [HKMD No.: 180534].

The manufacturer has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT/CT 3500/CT 5300 system. This component’s structural integrity may become compromised, resulting in potential contact with other gantry components located within the Incisive CT/CT 3500/CT 5300 system 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).

If you are in possession of the affected products, please contact your supplier for necessary actions.

Identified on 25 Apr 2024
Posted on 26 Apr 2024