China NMPA Product Recall - Endoscopic camera system

The National Medical Products Administration (NMPA) in China has announced a voluntary recall initiated by Olympus Medical Systems Co., Ltd. through its local entity, Olympus Trading (Shanghai) Co., Ltd. The recall, published on April 23, 2023, pertains to specific endoscopic camera systems (National Medical Device Registration Certificate No. 20182220250). The primary issue identified is an error in the cleaning and disinfection manuals for 4K cameras, which incorrectly stated that these devices could be sterilized using high-pressure methods. This erroneous instruction could lead to improper sterilization of the medical devices, potentially compromising patient safety and device efficacy. Classified as a Class III recall, this action requires the company to address the manual discrepancy and ensure all affected products are correctly managed to prevent further dissemination of the incorrect information and potential misuse. The comprehensive details regarding the specific models, specifications, and batches involved are provided in an attached Medical Device Recall Event Report Form, accessible via the NMPA website. This measure underscores the NMPA's commitment to ensuring the safety and correct use of medical devices within its jurisdiction.