Royal Philips (NYSE:PHG) has issued an urgent field safety notice about a software defect in its Azurion system.
The notice, issued last month in Europe, informed users of a problem that can occur when the user selects the “Add Study” function to add a new study to a patient when using the Azurion image-guided therapy platform.
In the software, the Add Study dialogue box is displayed where the patient type is selected to perform the study, but due to a software defect, when the study is initiated by selecting “Start Procedure,” the patient type changes to a different one than selected.
A change in patient type could lead to image quality degradation from a too-low radiation dose, or an unnecessary additional X-ray dose for the patient. No harm is expected from the additional radiation dose, according to the notice.
Amsterdam-based Philips said it has received nine customer complaints related to the issue, but no reports of harm associated with the problem.
The affected products are the Philips Azurion 7 M20 systems with the R2.0.x. software. The company said it would resolve the issue with a software update by the end of February 2022.