Updated with a clarification from Philips.
Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn users of an issue with its CombiDiagnost R90 GCF fluoroscopy system.
The imaging device used in radiography has shown an error issue when the table-tilting features are used. When using the “Table Up/Down” button on the device, Error 80, in which the device is locked in that specific state, may be experienced. When this happens, a system reboot can’t restore operation, meaning the intervention of a service engineer is required.
Should the device get stuck in a certain position, there is the potential hazard in which the non-moving table may lead to a contrast agent entering the brain, causing a headache until the patient is removed from the system.
Another issue that has arisen is with the system power distribution unit (SPDU). The SPDU is the main power supply for the system without the X-ray generator and includes a thermo switch to help with powering down in case of overheating. According to the safety notice, the switches may have been incorrectly installed and not functioning.
With the SPDU issue, overheating may result in the device generating smoke, which could lead to smoke inhalation and other related issues to patients, operators or bystanders.
Philips said that all CombiDiagnost R90 GCF systems are affected by the safety notice. Users are urged to avoid tilting the table with the “Table Up/Down” joystick and use the “Table Tilt Left/Right” joystick instead, as well as pay attention to the potential smoke issue with the SPDU.
To date, Philips has not received reports of patient, user or bystander harm in relation to these potential issues, according to a company spokesperson.
The company plans to install a system software update and perform on-site checks of the SPDU thermo contact at affected systems to eliminate the issues.