China NMPA Product Recall - Mammography equipment

Fujifilm (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific mammography equipment on January 25, 2019, as reported by the National Medical Products Administration (NMPA). This action was taken to ensure compliance with Chinese regulatory requirements. The recall addresses two distinct issues discovered by Fujifilm: an incorrect manufacturer's name printed on the labels of certain product batches and typographical errors found within the submitted technical documentation. Crucially, the NMPA document emphasizes that these identified issues do not compromise product safety, and customers can safely continue using the equipment. Fujifilm proactively undertook this recall as a corrective measure to align with regulatory standards, rather than due to any risk to patient health or equipment functionality. The "Medical Device Recall Event Report Form" provides further details on the specific models, specifications, and batches impacted by this recall. This highlights Fujifilm's commitment to regulatory adherence and transparent communication regarding minor compliance deviations.