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), as announced by the National Medical Products Administration (NMPA) on May 17, 2017. The recall stemmed from the company's failure to timely implement approved production process changes. On January 9, 2017, the Jiangsu Provincial Drug Administration had approved modifications to the product's structural composition and software version. However, products manufactured after this approval date did not conform to the updated technical specifications. The company's internal report on April 26, 2017, detailed this lapse in production organization. As required corrective actions, Suzhou Fujifilm will identify and manage all affected units, including one delivered but not yet installed and eleven in a company warehouse. These devices will be returned for necessary modifications and inspections to ensure they meet the revised technical requirements, before being released according to established protocols. The company has classified this as a Level 3 recall, deeming it not to fall under adverse event reporting.