China NMPA Product Recall - Monitor defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Class I recall for its monitored defibrillators, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. The company identified a critical issue related to the device's power supply. Specifically, damaged or contaminated battery connection pins can lead to inadequate power delivery. This defect causes the MRx(i) defibrillator to repeatedly restart when operating solely on a single battery, and it may also result in performance abnormalities when the device is disconnected from its main power source. Given the serious nature of these potential malfunctions, which could compromise patient safety, the company classified this as a Class I recall, signifying a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. As a required action, Philips (China) committed to recalling all affected products. Consumers and healthcare providers are directed to consult the "Medical Device Recall List" for comprehensive details on the specific models, specifications, and batches of defibrillators impacted by this recall.