China NMPA Product Recall - Mammography equipment

Fujifilm (China) Investment Co., Ltd. proactively initiated a voluntary Level III recall for specific batches of its mammography equipment, as reported on January 25, 2019. This action was taken to ensure full compliance with Chinese National Medical Products Administration (NMPA) regulations. The company identified two distinct issues through internal discovery, not an external inspection: firstly, certain component labels on the affected equipment contained incorrect manufacturer names; and secondly, typographical errors were present in the submitted technical documents. Fujifilm explicitly clarified that these issues do not pose any risk to product safety, allowing customers to continue using the mammography equipment without interruption. The Level III classification signifies that the issue is unlikely to cause adverse health consequences, but correction is still necessary for regulatory conformity. This voluntary recall underscores Fujifilm's commitment to maintaining meticulous accuracy in product labeling and documentation, reinforcing their adherence to stringent regulatory frameworks even when patient safety is not compromised. Detailed information regarding the precise models, specifications, and batches involved is provided in the "Medical Device Recall Event Report Form" attachment.