China NMPA Product Recall - Digital mammography X-ray diagnostic system

Fujifilm (China) Investment Co., Ltd. initiated a voluntary Level II recall of its Digital Mammography X-ray Diagnostic System on November 13, 2017. The recall was prompted by a compliance issue where the relevant Chinese labels for the product were not updated promptly following the issuance of a new product registration certificate. This labeling oversight did not indicate a defect in the device's functionality or safety, but rather a regulatory discrepancy concerning product identification documentation. Under the oversight of the National Medical Products Administration (NMPA), Fujifilm (China) is taking corrective action to address this administrative non-compliance. The company is actively recalling specific models, specifications, and batches of the affected digital mammography systems, with detailed information provided in a Medical Device Recall Event Report Form. This voluntary action ensures that all distributed products adhere strictly to current national medical device labeling regulations as stipulated by the NMPA, reinforcing transparency and regulatory adherence within the medical device market. The recall demonstrates the company's commitment to maintaining accurate product information in accordance with Chinese regulatory standards.