China NMPA Product Recall - Medical diagnostic X-ray system

Philips Medical Systems DMC GmbH, through its agent Philips (China) Investment Co., Ltd., initiated a voluntary Class III recall of its medical diagnostic X-ray systems, as reported to the National Medical Products Administration (NMPA) on November 14, 2018. The recall stems from a software defect that presents two primary issues. Firstly, the kV/mA lockout function, intended to maintain consistent radiation parameters during fluoroscopy, malfunctions. Due to the defect, the mA value can increase unexpectedly after the lockout function is activated and fluoroscopy pulses are restarted, leading to an increased radiation dose for the patient. Secondly, when using the SkyPlate detector, the system may abort the stitching process after the first image due to improper synchronization, resulting in artifacts in the preview image and requiring repeated runs. While these issues were identified, the affected batches of the CombiDiagnost R90 model were not sold in China. This proactive measure aims to address potential patient and user risks associated with these identified software anomalies.