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

Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall for 12 units of its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234). The National Medical Products Administration (NMPA) publicized this recall on May 3, 2017, following the company's report on April 26, 2017. The primary issue was a failure to promptly implement approved structural changes and software upgrades, which the Jiangsu Provincial Drug Administration had approved on January 9, 2017. Products manufactured after this date did not conform to the updated regulatory requirements, although this was not classified as an adverse event. As a corrective action, Suzhou Fujifilm will identify one unit delivered to a hospital but not yet installed, and eleven units still in the Fujifilm (China) Investment Co., Ltd. warehouse. All affected units will be transported back to the company for modification and inspection to ensure compliance with revised technical requirements before redelivery.