China NMPA Product Recall - Patient monitor

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its patient monitors, as reported to the National Medical Products Administration (NMPA) on December 28, 2018, with the announcement published on January 7, 2019. The recall stems from a critical safety concern regarding the lithium batteries used in these devices. The primary issue identified was that the patient monitor's service guides lacked sufficient instructions for users to effectively monitor battery life and determine appropriate replacement times. Specifically, users were not adequately guided on how to obtain information regarding battery capacity or charge-discharge cycles, which are crucial for timely battery replacement (when capacity drops below 80% or after 300 cycles). This deficiency posed a risk of battery overheating or combustion after exceeding its service life. To address these issues, Philips Kinco is required to publish a service guide appendix to include comprehensive information on battery management and replacement. Additionally, the company must implement software improvements to incorporate user prompts, thereby simplifying battery life management for healthcare professionals. This recall affects various models, including CM10, CM12, CM100, CM120, and CM150, impacting a significant quantity of units in China.