China NMPA Product Recall - Automated External Defibrillator

Physio-Control, Inc. initiated a voluntary Class I recall of its Automated External Defibrillators (AEDs), specifically the LIFEPAK CR PLUS model, as reported by the National Medical Products Administration (NMPA) on November 25, 2016. The recall addresses a critical safety issue where an internal component, the reed switch, can intermittently remain in the OFF position after the device cover is opened and the ON/OFF button is pressed. This malfunction prevents the AED from activating voice prompts and delivering a therapeutic electrical shock, rendering the device ineffective in treating patients experiencing cardiac arrest. Although no patient treatment delays due to this specific issue have been reported, the potential for therapeutic failure prompted the highest level of recall. Physio-Control's responsible unit in China, Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., confirmed that the recall is global. As a corrective action, customers have been notified, and arrangements are being made to calibrate all affected devices, which includes replacing the faulty reed switch assembly or providing alternative devices to ensure patient safety and device functionality. This action aligns with the NMPA's regulatory oversight to protect public health.