China NMPA Product Recall - LIFEPAK CR PLUS

Physio-Control, Inc. initiated a Class I voluntary recall of its Automated External Defibrillators (AEDs) (NMPA Registration No.: 20163212102), as reported to the National Medical Products Administration (NMPA) on November 24, 2016, and published on November 25, 2016. The recall was prompted by a critical issue where, after opening the cover and pressing the ON/OFF button, devices intermittently failed to activate voice prompts. This malfunction stems from an internal component, a reed switch, becoming fixed in the OFF position, preventing the defibrillator from delivering a life-saving shock. Such a failure could result in the inability to achieve therapeutic efficacy and effectively defibrillate patients experiencing cardiac arrest. The affected products, including the LIFEPAK CR PLUS model, were distributed globally. Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. is the responsible unit in China. In response to this serious defect, Physio-Control, Inc. has informed all affected customers about the issue. The company has arranged for corrective actions, which include comprehensive device calibration. This calibration involves either replacing the faulty reed switch assembly in the affected devices or providing alternative, fully functional devices to ensure patient safety and product efficacy. This recall highlights the manufacturer's responsibility under the NMPA framework to address critical medical device defects promptly.