China NMPA Product Recall - sound processor

The National Medical Products Administration (NMPA) published a notice on June 17, 2019, regarding a voluntary Class III recall initiated by Cochlear Bone Anchored Solutions AB. This recall, reported by Cochlear Medical Devices (Beijing) Co., Ltd., pertains to a sound processor (Registration Certificate No. 20182461914). The core issue identified is a potential labeling error associated with the device. This document is a recall announcement rather than an inspection report, therefore, specific inspection dates are not applicable or mentioned. The regulatory framework for this action is the NMPA, China's national authority for medical products. A Class III recall indicates that the use of or exposure to the affected product is unlikely to cause adverse health consequences. The required action is the voluntary withdrawal of the identified sound processor from the market. Comprehensive details concerning the affected product model, specifications, and batch numbers are contained within an accompanying "Medical Device Recall Event Report Form," which guides the implementation of the recall process.