Important Safety Alerts

Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Continuous CT Fluoroscopy Digital Visual Interface (DVI) Ceiling Mount.

According to the manufacturer, significant wear of the Monitor Bracket Assembly shaft that goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm. If the Monitor Bracket Assembly were to detach from the Suspension Arm, there is a potential hazard for the monitor to fall while remaining attached to the cables. There is a potential that patient, operator, bystander, or service person located in the path of a falling part could sustain injury or may lead, in rare and specific circumstances, to serious injury or even death. There have been no reports of death or serious injury.

The manufacturer is instructing affected users to take the following actions:

• Inspect the joint area of the Continuous CT DVI Ceiling Mount Arm to ensure that the safety clip is installed
• Stop using the suspension monitor and move the monitor arm away from any person if the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm.

The manufacturer is planning to inspect and correct the issue.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 5 May 2021