China NMPA Product Recall - Electronic duodenoscope

Fujifilm (China) Investment Co., Ltd., in coordination with its parent company Fujifilm Corporation, initiated a Class II voluntary recall of several models of electronic duodenal endoscopes. This recall, reported to the National Medical Products Administration (NMPA) on February 7, 2016, and publicly announced on April 21, 2016, addresses a critical safety concern related to the devices' complex structural design. The design complexity was identified as potentially hindering effective cleaning and disinfection, thereby increasing the risk of contaminants not being adequately removed if cleaning instructions are not rigorously followed. Although no patient injuries have been reported to date, the company recognized the potential for reduced safety and proactive steps were deemed necessary under NMPA oversight. To mitigate this risk, Fujifilm (China) is implementing two key actions: first, issuing formal notification letters to customers to inform them of the associated risks and emphasize the importance of adhering to standardized cleaning and disinfection procedures. Second, the company will deploy its after-sales service engineers to customer sites to provide comprehensive training and on-site guidance on the correct and critical steps for cleaning and disinfecting the affected duodenal endoscope models.