China NMPA Product Recall - Monitor/Defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its HeartStart MRx Monitor/Defibrillator, publicly announced on July 29, 2020, under the oversight of the National Medical Products Administration (NMPA). The recall addresses a critical malfunction in the device's energy selection switch, which controls power, mode, and energy settings. This defect can prevent the defibrillator from performing selected functions, changing energy settings, or delivering shocks at the user-specified energy level. Such issues pose a significant risk, potentially causing treatment delays or a complete failure to deliver essential therapy. The company's action, documented internally as FCO86100212, reflects its adherence to the NMPA's regulatory framework and its commitment to patient safety. The recall requires the removal of all affected devices from circulation, with specific details on models, specifications, and batches available in the accompanying "Medical Device Recall Event Report Form."