China NMPA Product Recall - Patient monitors (Models: Efficia CM10, CM100, CM12, CM120, CM150)

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class III recall of several patient monitor models, including Efficia CM10, CM100, CM12, CM120, and CM150. This action, publicly announced on July 5, 2022, was prompted by internal monitoring that revealed a potential malfunction in the Efficia CM. FPGA component. This issue could lead to the disappearance of crucial detection parameter values during operation, potentially impacting patient care. The recall addresses a critical product performance issue under the oversight of the National Medical Products Administration (NMPA). Philips Kinco is responsible for implementing the necessary corrective actions to ensure the safety and reliability of its medical devices, aligning with regulatory expectations for medical device quality and post-market surveillance. Detailed information on affected product batches is available in the associated "Medical Device Recall Event Report Form".