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), as announced by the National Medical Products Administration (NMPA) on May 12, 2017. The recall stems from the company's failure to adapt production processes promptly following a registration change approved by the Jiangsu Provincial Drug Administration on January 9, 2017. This approval pertained to modifications in the product's structural composition and a software version upgrade. Consequently, systems manufactured after this approval date did not conform to the updated regulatory requirements. The company reported this issue on April 26, 2017. The affected units, comprising one delivered but uninstalled system and eleven units held in a warehouse by Fujifilm (China) Investment Co., Ltd., are intended for general X-ray imaging, excluding mammography or dental applications. The required actions involve the immediate identification, management, and return of these products to Suzhou Fujifilm. They will then undergo necessary modifications and inspections to align with the revised technical specifications before being redistributed. The company determined that this situation does not constitute an adverse event requiring reporting.