China NMPA Product Recall - Defibrillator; Defibrillator/Monitor; Monitor/Defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for specific defibrillators and monitor/defibrillators on October 13, 2020. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a critical safety concern identified in intrathoracic on/off defibrillator electrode plates. Products manufactured and distributed between January 2015 and August 2020 were found to be susceptible to insulation loss between conductors after multiple use cycles, posing potential risks to patient safety and device performance. The affected devices fall under registration certificates including CFDA (Imported) 2013 No. 3211057, CFDA Import Registration No. 20173211027, and CFDA Import Registration No. 20163214004. Philips (China) Investment Co., Ltd. is actively retrieving these impacted devices from the market. Further details regarding specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" accessible via the NMPA website. This proactive measure reflects the company's commitment to product safety and adherence to regulatory standards.