China NMPA Product Recall - Naida CI Q30 sound processor, Naida CI Q70 sound processor, Naida CI Q90 sound processor

Advanced Bionics AG, the manufacturer, initiated a voluntary Level III recall of its Naida CI sound processors due to a labeling error. This recall, reported to the National Medical Products Administration (NMPA) and its provincial food and drug administration department on February 25, 2019, and officially published on March 11, 2019, addresses a discrepancy where two sound processors pre-installed with Naida CI Q70 firmware were incorrectly labeled as Naida CI Q90. The affected products include specific models like Naida CI Q30, Q70, and Q90 sound processors, with eight units identified by unique identification information. While the company stated that this error poses no risk to user safety or health, Advanced Bionics AG, with its agent Leading Bionics Medical Devices (Shanghai) Co., Ltd., decided to undertake corrective actions. The required actions involve contacting users to provide new, correctly labeled sound processors as replacements for the eight affected devices. The returned units will undergo quarantine and proper disposal. Importantly, all affected devices were identified before shipment to China, ensuring that domestic customers are not impacted by this recall. The regulatory framework for this recall falls under the NMPA's medical device oversight.