China NMPA Product Recall - Digital medical X-ray imaging system

On February 21, 2020, Suzhou Fujifilm Imaging Equipment Co., Ltd. voluntarily initiated a Class III recall for its Digital Medical X-ray Imaging System, identified by NMPA Registration Certificate 20152060234, across Mainland China. The recall was necessitated by an error found in the Chinese instruction manual CD, Version H, which contained an inaccurate description of the bulb situated within the collimator component. Affected products include models with identification numbers such as 87235066 and 97135095.

Operating under the regulatory guidance of the National Medical Products Administration (NMPA), the company assessed the situation and confirmed that this discrepancy did not constitute an adverse event, and the operational integrity of the Digital Medical X-ray Imaging System remains uncompromised, allowing continued use. The primary corrective action involves the company replacing the incorrect instruction manual CD (Version H) with the accurate Version I to ensure precise product documentation for all affected devices. This action underscores the company's commitment to maintaining high standards of product information within the medical device sector.