China NMPA Product Recall - Electronic duodenoscope

Olympus Medical Systems Co., Ltd. has initiated a voluntary Class III recall of certain electronic duodenoscopes, a measure reported to China's National Medical Products Administration (NMPA) on February 5, 2024. This action was conveyed by Olympus Trading (Shanghai) Co., Ltd., the local entity. The primary issue necessitating the recall is a manufacturing defect where the tip cap on the electronic duodenoscope cannot completely cover the device. This malfunction could potentially affect the device's performance or safety during medical procedures.

The specific affected product is identified by serial number 20182062531. A Class III recall is typically implemented for products with issues that are unlikely to cause serious adverse health consequences but still require corrective action due to non-compliance or minor defects. Olympus's voluntary recall underscores the company's commitment to maintaining high product quality and ensuring patient safety, in adherence to regulatory standards set by the NMPA. Additional comprehensive details concerning specific models, product specifications, and batch numbers are available in the official 'Medical Device Recall Event Report Form' provided by the company, ensuring transparency and proper regulatory compliance.