China NMPA Product Recall - Monitor defibrillator

On July 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Philips Medical Systems, distributed by Philips (China) Investment Co., Ltd. The recall addresses a critical safety concern related to specific monitored defibrillators (Registration Certificate No.: 20163214004). The core issue involves a potential defect in a gas discharge tube (GDT) within these devices. This defect can lead to interference, manifesting as noise on the electrocardiogram (ECG) signals received via the electrode pads. Such interference poses a significant risk by potentially hindering medical professionals from accurately identifying shockable cardioversion rhythms, which could delay or prevent necessary life-saving interventions. Philips Medical Systems voluntarily initiated this recall to mitigate patient safety risks associated with the device's performance degradation. The company provided detailed information regarding affected registration numbers, specifications, and batch numbers in an attached Medical Device Recall Event Report Form.