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

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Fujifilm (China) Investment Co., Ltd., regarding its Digital Mammography X-ray Diagnostic System (model FDR MS-1000). The recall, publicized on September 30, 2016, addresses a significant software anomaly. The issue arises during stereotactic puncture exposure: if the exposure switch is released between 3.0 and 3.3 seconds of the C-arm rotation, the system software may generate an error. This malfunction can prevent exposure from continuing and may not allow automatic or manual resumption, potentially disrupting diagnostic procedures. Five units of the affected system were produced or imported into China, with four units sold domestically. Fortunately, no injury incidents related to this issue have been reported to date. Under the NMPA's regulatory framework, Fujifilm (China) Investment Co., Ltd. is obligated to implement specific corrective actions. These include dispatching formal notification letters to inform all affected customers about the identified risks. Additionally, on-site service engineers will contact these customers to arrange and perform necessary software upgrades. They will also provide comprehensive instructions on managing this specific issue to ensure operational continuity and patient safety.