Philips Healthcare issues field safety notice for two system errors.
Philips Healthcare has announced a field safety notice for its CombiDiagnost R90 GCF system, a cross-functional system that can perform radiography and radiography/fluoroscopy studies.
The company identified two errors and noted the safety notice affects all CombiDiagnost R90 GCF systems.
First, when used in radiography, the device has indicated an error issue with the table-tilting features. When using the “Table Up/Down” button, CombiDiagnost R90 can become locked in position and be unable to perform a system re-boot to restore normal operations. This error is hazardous because, in a certain position, it could cause a contrast agent to enter the brain, leading to a headache for the patient.
Second, the thermo switch in the system power distribution unit (SPDU) that shuts the system down in cases of overheating may have been installed incorrectly, preventing proper function. Any overheating could cause the device to create smoke, leading to smoke inhalation issues for patients, operators, and anyone else nearby.
According to the company, there have been no reports of any harm caused due to these issues. Philips plans to install a system software update and perform on-site check of the SPDU thermo contact to eliminate these issues.