China NMPA Product Recall - Portable color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system; color ultrasound diagnostic system

On September 23, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its portable color ultrasound diagnostic systems and several other color ultrasound diagnostic system models. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical manufacturing defect affecting specific S7-3t and S8-3t TEE probes. The primary issue identified was improper programming during the manufacturing process of these transesophageal echocardiography (TEE) probes. This programming error results in the system's inability to accurately measure the temperature at the probe tip, potentially posing a safety risk. Philips (China) is taking proactive measures under the NMPA's regulatory framework to ensure patient safety and product quality. The recall requires affected devices to be addressed, with detailed information regarding specific product models, specifications, and batches provided in the accompanying 'Medical Device Recall Event Report Form'. This voluntary recall underscores the company's commitment to promptly addressing product deficiencies and complying with regulatory standards.