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

Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall of 12 units of its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234). The recall was publicly announced by the National Medical Products Administration (NMPA) on May 12, 2017, following the company's report on April 26, 2017. The primary issue arose from a delay in organizing production according to revised requirements after the Jiangsu Provincial Drug Administration approved changes to the product's structural composition and software on January 9, 2017. As a result, units manufactured after this date did not conform to the updated approval document. Under the NMPA's regulatory framework, the company's required actions involve immediately identifying, retrieving, and transporting all 12 affected units back to Suzhou Fujifilm. These products will then be modified and thoroughly inspected to ensure full compliance with the updated technical specifications before re-release.