China NMPA Product Recall - electrocardiograph

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall for its PageWriter TC20, TC30, and TC50 electrocardiographs, as reported on December 29, 2018, to the National Medical Products Administration (NMPA). The recall addresses a critical safety concern related to the lithium batteries in these devices. The primary issue identified was the inadequacy of information within the product service guides. While the electrocardiographs can display crucial battery life and charge-discharge cycle data, the existing documentation failed to sufficiently guide users on how to access this information or determine the appropriate time for battery replacement. This deficiency posed a safety risk, as expired lithium batteries are prone to overheating or combustion. Batteries should be replaced when their capacity drops below 80% or after 300 charge-discharge cycles. To rectify this, Philips Kinco is implementing corrective actions. These include issuing an appendix to the service guides that will provide comprehensive information on battery management and replacement procedures. Furthermore, software upgrades will be deployed to integrate user-friendly prompts, simplifying battery life monitoring and ensuring timely replacement. This proactive measure aims to enhance patient safety and device longevity by providing clear guidance to users.