China NMPA Product Recall - electrocardiograph

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall for its electrocardiographs, including models PageWriter TC20, TC30, and TC50, with the recall event reported to the National Medical Products Administration (NMPA) on December 29, 2018. The recall, affecting 2650 units in China and globally, stemmed from a critical safety issue: the existing service guides lacked sufficient information to instruct users on monitoring battery life, charge-discharge cycles, and the appropriate time for replacement. This deficiency posed a risk of lithium batteries overheating or burning once they exceeded their service life, specifically when their capacity fell below 80% or after 300 charge-discharge cycles. In response, Philips Kinco is implementing corrective actions, including releasing a service guide appendix to provide comprehensive instructions on battery management and replacement, and deploying software upgrades to add user prompts, thereby enhancing battery life management for medical professionals. This proactive measure aims to improve product safety and ensure users have clear guidance for the safe operation and maintenance of these essential medical devices.