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

Suzhou Fujifilm Imaging Equipment Co., Ltd. has initiated a voluntary Class III recall for 12 units of its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234). This recall, reported to the National Medical Products Administration (NMPA) on April 26, 2017, stems from the company's failure to adhere to production requirements following an approved registration change. Specifically, the Jiangsu Provincial Drug Administration approved changes to the product's structural composition and software version on January 9, 2017. However, due to delays in implementing these production process changes, units manufactured subsequent to this approval date did not conform to the updated technical specifications. The affected products, intended for general X-ray imaging for clinical diagnosis, were distributed within Mainland China. As part of the corrective actions, Suzhou Fujifilm will identify and manage the involved products, which include one unit delivered but not yet installed at a hospital, and eleven units stored in a warehouse. These systems will be transported back to the company, modified, and re-inspected to ensure full compliance with the updated technical requirements approved post-registration change. The recall aims to ensure product integrity and adherence to regulatory standards established by the NMPA. The company assessed this event as not requiring adverse event reporting.