China NMPA Product Recall - Ultrasound diagnostic system

On November 16, 2018, the National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Esaote S.p.A., through its agent Esaote (Shenzhen) Medical Equipment Co., Ltd., for several models of its ultrasound diagnostic systems. The recall addresses a critical software defect that causes incorrect default settings when the ElaXto mode (elastic ultrasound application) is activated. This malfunction could lead to the overheating of probes, posing a potential safety risk to patients and users. The affected products include various models such as MyLab 60, MyLab 70 XVision, MyLab 65, MyLab70 XVG, MyLab90, MyLab 75, MyLab Class C, MyLab Class C Advanced, MyLabTwice, and MyLabTwice eHD. These systems are used for general ultrasound diagnosis and were distributed across numerous countries, including China, Italy, the United States, and Germany, among others. Under the NMPA's regulatory oversight, Esaote S.p.A. is required to undertake specific corrective actions. These include promptly notifying all affected users of the issue, developing and releasing a defect repair software, and subsequently installing this corrective software on all impacted customer devices to resolve the identified overheating risk. The recall aims to ensure the safe and proper functionality of the medical devices.