China NMPA Product Recall - ECG cable (Model: 989803160641)

The National Medical Products Administration (NMPA) issued a Recall Event Report on November 26, 2018, regarding Philips Kincoway (Shenzhen) Industrial Co., Ltd. The recall addresses a critical safety issue with their Electrocardiogram Cable, model 989803160641. The main concern is that during simultaneous defibrillation or cardiopulmonary resuscitation, the cable may divert some of the defibrillation energy away from the patient's chest. This diversion could result in an insufficient energy dose, potentially leading to the patient not receiving the expected life-saving treatment. Operating under the NMPA's regulatory oversight, Philips initiated a Level II recall. The corrective action targets 2101 affected ECG cables compatible with G30E and G40E monitor models. These specific affected accessories were not sold in the Chinese market but were distributed to overseas markets. To rectify the issue, Philips Kincoway (Shenzhen) Industrial Co., Ltd. is committed to replacing all impacted ECG cables free of charge. Customers are required to submit a completed response form to facilitate the order and shipment of updated replacement cables, ensuring patient safety and product efficacy.