China NMPA Product Recall - Electronic bronchoscope

Olympus Medical Systems Co., Ltd., through its subsidiary Olympus (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its BF-XT160 electronic bronchoscope and the BF-XF160 repair kit (NS kit). This action, reported on August 25, 2021, to the National Medical Products Administration (NMPA), addresses a critical manufacturing defect. The primary issue identified was the insufficient adhesion between the endoscope tubing and the insertion tip during the production process. This flaw could potentially compromise the safety and functionality of the device during medical procedures. The affected products are associated with Registration Certificate No.: CFDA (Imported) 2006 No. 3220262. The Class II recall designation signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Olympus Medical Systems Co., Ltd. is taking responsibility for this manufacturing discrepancy by undertaking this voluntary recall. Further detailed information regarding the specific specifications and batches involved in this recall event is provided in the accompanying "Medical Device Recall Event Report Form" attachment, available on the NMPA website. This measure ensures patient safety and compliance with medical device quality standards.