China NMPA Product Recall - Electronic bronchoscope (trade name: EVIS EXERA II)

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Electronic Bronchoscope, specifically the EVIS EXERA II (model BF-Q180), on August 31, 2020. This action was prompted by an internal post-marketing risk assessment revealing a higher probability of patient infection associated with the BF-Q180 model compared to other Olympus bronchoscopes. The recall impacts products registered under Certificate No.: CFDA (Imported) 2012 No. 3221125, with detailed affected models, specifications, and batches provided in an accompanying Medical Device Recall Event Report Form. This regulatory action was reported by the Shanghai Municipal Drug Administration, operating under the oversight of the National Medical Products Administration (NMPA). The company proactively addressed the identified patient safety concern by implementing this recall to mitigate potential health risks to users.