China NMPA Product Recall - Ultrasound diagnostic instrument

GE Healthcare (China) Co., Ltd. initiated a voluntary Class III recall of 98 units of its ultrasonic diagnostic instruments, including LOGIQ V1 and LOC models, with a publication date of October 23, 2018. This action, reported to the National Medical Products Administration (NMPA), addresses a compliance issue within the product's Chinese user manual. The primary violation involved the omission of critical registration information in the manual, such as the product name, registration date, after-sales service details, medical device registration license number, and product technical specifications, which are mandatory under Chinese regulations. The company clarified that despite the manual discrepancy, the instruments' functionality and safety are unaffected, and users can continue their operation. No adverse feedback has been received regarding this issue. As part of the required actions, GE Healthcare committed to issuing customer letters to inform users of the situation and conducting online or on-site reviews of the affected products to ensure appropriate handling and compliance with the recall requirements. This proactive measure reflects the company's dedication to maintaining high standards of product quality and regulatory conformity.