China NMPA Product Recall - electrocardiograph

On January 15, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its electrocardiograph (ECG) machines, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stemmed from internal product complaints revealing that the lithium-ion batteries in these ECG devices were overheating and burning, exceeding their expected operational lifespan. A primary issue identified was incomplete product labeling. The existing instructions failed to provide clear guidance on when to replace the battery, specifically omitting criteria such as exceeding 300 charge-discharge cycles or when battery capacity drops below 80% of a new battery. This lack of comprehensive instructions meant users might not replace batteries at the appropriate time, potentially leading to safety concerns. As a required action, Philips (China) Investment Co., Ltd. is recalling affected electrocardiograph models. Detailed information regarding the specific models, specifications, and batches involved in this recall is accessible in the accompanying "Medical Device Recall Event Report Form".