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 primary issue identified was a discrepancy between the product's instruction manuals and its official registration certificate, specifically concerning the declared scope of application. The recall covers various models, including LHZ-300, LHZ-600, and LHZ-700, with a total of 70 affected units across multiple batch numbers. The company took proactive steps under the NMPA's medical device recall framework, although no adverse events related to this inconsistency have been reported. The required corrective actions involve two main steps: first, issuing a formal recall notice and retrieving all non-conforming instruction manuals from circulation. Second, the company committed to replacing these faulty manuals with updated, revised versions for all affected users, ensuring consistency with the product's registration and aligning with regulatory requirements.