China NMPA Product Recall - Ultrasonic therapy device

Luoyang Kangli Medical Device Co., Ltd. initiated a voluntary Level III recall of its ultrasonic therapy devices in August 2019, as reported to the National Medical Products Administration (NMPA). The recall was prompted by a significant discrepancy between the product's instruction manuals and its official registration certificate, specifically regarding the approved scope of application for the devices. While no adverse events have been reported to date as a result of this inconsistency, the company recognized the need for corrective action to ensure compliance and accurate product information for users. The affected devices include various models such as LHZ-300, LHZ-600, and LHZ-700, encompassing 70 units across multiple batch numbers. To rectify the issue, Luoyang Kangli Medical Device Co., Ltd. is required to issue a comprehensive recall notice to retrieve all non-conforming instruction manuals. Furthermore, the company must provide revised and compliant instruction manuals to all users, ensuring that all affected parties receive accurate documentation that aligns with the product's official registration.