China NMPA Product Recall - Dual-energy X-ray bone densitometer

Fujifilm Corporation (Fujifilm K. Co., Ltd.), through its subsidiary Fujifilm (China) Investment Co., Ltd., has initiated a voluntary Class III recall for its dual-energy X-ray bone densitometer. The core issue prompting this recall is a printing error identified in the product's unique medical device identification mark. This crucial mark is vital for regulatory compliance and product traceability, and its inaccuracy necessitates this corrective action. The affected devices are specifically those registered under National Medical Device Registration Certificate No. 20212060266. This regulatory event was publicly announced by the National Medical Products Administration (NMPA) on August 29, 2025. It is noteworthy that the particular products implicated in this recall were not imported into the Chinese market, thus limiting direct impact within China. Fujifilm (China) Investment Co., Ltd. has submitted a comprehensive 'Medical Device Recall Event Report Form,' detailing the specific models, specifications, and batch numbers involved. This voluntary recall underscores Fujifilm's commitment to product quality, safety standards, and adherence to global regulatory reporting protocols.