China NMPA Product Recall - Defibrillator/Monitoring Defibrillator Accessories - Defibrillator Electrode Plates

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary recall of its sterile intrathoracic defibrillator electrode plates, accessories for defibrillators/monitoring defibrillators. The recall was publicly announced on October 20, 2020, under the oversight of the National Medical Products Administration (NMPA). The primary issue identified was that standard periodic electrode checks, as recommended in the product's instructions for use, might not adequately detect an on/off insulation failure mode within the defibrillator electrode plates. This critical defect could prevent the device from delivering the necessary electrical energy to patients, posing a significant safety risk. Philips Kinco proactively decided to recall the affected products to address this potential malfunction. Detailed information regarding the specific models, specifications, and batch numbers of the impacted devices is available in the company's Medical Device Recall Event Report Form. The company is taking corrective action to ensure patient safety and product reliability by removing the problematic electrode plates from circulation.