China NMPA Product Recall - Electronic bronchoscope

Olympus Medical Systems Co., Ltd., through its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its electronic bronchoscopes. This action, reported on December 20, 2023, is in response to a critical omission in the product's operation manual: the absence of essential product specification charts. The recall specifically impacts electronic bronchoscope models associated with National Medical Device Registration Certificates 20172066061 and 20182062271, including Giant 20153223034. This voluntary recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) in China. The primary issue identified is a documentation deficiency rather than a direct product malfunction, which could potentially affect safe and proper use. Detailed information regarding the specific models, specifications, and affected batches is available in the accompanying "Medical Device Recall List" and the "Medical Device Recall Event Report Form" submitted by Olympus Trading (Shanghai) Co., Ltd. The company is undertaking this recall to ensure compliance with regulatory standards and to maintain the safety and efficacy of its medical devices by rectifying the user manual documentation.