Medical device manufacturer, Philips, issued a medical device safety alert concerning its DigitalDiagnost 1.x, 2.x, 3.x, 4.x, BuckyDiagnost, EasyDiagnost, TraumaDiagnost, ProGrade, ProxiDiagnost N90, and CombiDiagnost R90 Radiography Systems (that use ceiling suspension).
According to the manufacturer, if a user, while cleaning or disinfecting the control handle of the ceiling suspension, uses excessive liquid or if liquid is sprayed directly on the system, it is possible for liquid to enter around the edges of the button onto the movement activation switch creating a short circuit and activation of the brake release. Activation of the brake release could allow for unintended motion of the ceiling suspension in the lateral and horizontal axis. Since the system is counterbalanced and levelled during installation in X & Y directions, external force is needed to move the ceiling suspension. This is not an issue once the disinfectant dries off from the switch assembly.
The manufacturer did not identify any no safety risk to patients or users associated with this issue. The manufacturer is instructing operators to continue use the device according to its intended use.
The manufacturer is also reminding affected users to follow the cleaning and disinfecting instructions provided in the Maintenance, Cleaning and Disposal section of the Instructions for Use.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Dec 2021