China NMPA Product Recall - Monitor/Defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its HeartStart MRx Monitor/Defibrillator, as reported by the National Medical Products Administration (NMPA) on May 22, 2020. The company's internal monitoring identified that a specific range of these medical devices were inadvertently excluded from previous field procedures. Consequently, these affected HeartStart MRx units may not have undergone essential corrective actions that were mandated. This oversight presents a significant risk, potentially leading to critical delays in patient treatment or the complete failure to deliver the anticipated medical intervention when the defibrillator is needed. Philips (China) has therefore undertaken this recall to address the potential safety concerns arising from the unperformed corrective measures. While the general nature of the issue involves omitted maintenance, specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action aligns with the NMPA's regulatory oversight to ensure the safety and efficacy of medical devices within China.