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

On September 15, 2023, the National Medical Products Administration (NMPA) published a notification regarding a voluntary Class II recall initiated by Fujifilm Corporation. This recall pertains to certain batches of its Digital Mammography Diagnostic Systems, specifically those covered by National Medical Device Registration Certificates 20143306002 and 20143066002.

The primary issue identified by Fujifilm (China) Investment Co., Ltd. involves the Computed Enhanced Digital Mammography (CEDM) optional functions. These functions were present in specific product batches but were not included within the scope of the original registration and certification in Japan. This discrepancy poses a risk of misleading use by operators or patients, highlighting a potential misalignment between product capabilities and their officially approved specifications.

As a corrective measure, Fujifilm Corporation is voluntarily recalling the affected digital mammography diagnostic systems. While the document specifies a Class II recall, it emphasizes that detailed information concerning the exact affected product models, specifications, and batch numbers is available in the "Recall Event Report Form" provided as an attachment. This action underscores the company's commitment to product safety and compliance with regulatory standards, ensuring that medical devices function strictly within their certified parameters to prevent potential patient harm or misdiagnosis.