China NMPA Product Recall - Computed Tomography X-ray Imaging Reader System

Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall of its Computed Tomography (CT) X-ray Imaging Reader Systems in mainland China, as reported on January 10, 2017, and subsequently published by the National Medical Products Administration (NMPA) on January 12, 2017. The primary concern involved the product's Quantum Detection Efficiency (DQE), which indicates image quality. The DQE value was found to deviate from the company's registered specifications for the Chinese market, even though it met Fujifilm's unified global sales specifications. No patient injuries have been reported related to this issue. The recall affects four units across FCR CAPSULA XLII and FCR CAPSULA X models. As part of the required actions, three unsold units from a warehouse will be returned to the factory for repair and re-inspection. Additionally, one unit that had been installed in a hospital will be isolated and disposed of. This recall underscores the importance of adhering to specific local regulatory registration standards.