China NMPA Product Recall - Digital mammography system

On December 21, 2021, Fujifilm (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific batches of its digital mammography system. This action was reported under the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall stems from a discrepancy where the product name printed on the certificates for certain batches of the digital mammography equipment did not match the product's officially approved registered name. Crucially, the company has clarified that this naming inconsistency poses no risk to product safety or performance. Fujifilm (China) Investment Co., Ltd. is proactively withdrawing the affected units to address this administrative non-conformity. The specific models, specifications, and batch numbers subject to this recall are detailed in a supplementary Medical Device Recall Event Report Form. This voluntary recall underscores the company's commitment to adhering to regulatory standards, even for issues not directly impacting patient safety, ensuring accuracy in product documentation and compliance with established regulatory frameworks governing medical devices in China.