Philips Healthcare has initiated a field safety notification to correct issues with its CombiDiagnost R90, a cross-functional system that performs both radiography and radiography/fluoroscopy (R/F) studies.
Philips identified two issues with the CombiDiagnost R90, one that involves the table movement controls and another that affects its system power distribution unit (SPDU).
With respect to table movement, the company found that under certain conditions the "table tilt up/down" button could cause an error that locks the table in its existing position; a field service engineer would be required to correct the problem, which could delay patient care or cause patient discomfort.
With the SPDU issue, Philips has discovered that some customers have systems with an incorrectly installed thermo switch, which is used to power down the system if the transformer becomes overheated; for some units, this can cause the unit to generate smoke.
Philips noted that it has not received any reports of patients being harmed by either of the issues. Philips said it will initiate a field service correction between January 2020 and July 2020 to fix the issues.
