China NMPA Product Recall - Electronic colonoscopy

Olympus Medical Systems Co., Ltd., facilitated by Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for specific electronic colonoscopes and electronic duodenal endoscopes. The core concern driving this recall is an uncertain water tightness discovered in these medical devices. While the manufacturer is Olympus Medical Systems Co., Ltd., its Shanghai trading arm reported the action to the National Medical Products Administration (NMPA) in China. The affected products, registered under NMPA certificates 2020306 and 20182062531 respectively, were not imported into the Chinese market. This means the recall addresses products distributed elsewhere globally, with the report to the NMPA serving as a transparency measure within the established regulatory framework. A Class III recall typically signifies a situation where the likelihood of adverse health consequences is low. Detailed information regarding the specific models, specifications, and batches involved is outlined in the accompanying "Medical Device Recall Event Report Form." This action underscores Olympus's commitment to product safety and adherence to international quality standards.