China NMPA Product Recall - Proton therapy system

On March 31, 2017, the National Medical Products Administration (NMPA) announced a Class II voluntary recall by Ion Beam Applications S.A. for its proton therapy systems. Initiated by its Chinese entity, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., the recall addresses a critical safety defect. The primary issue is that the system's rotating gantry may operate when the treatment nozzle is not securely locked. This malfunction occurs because metal shavings can accumulate near a limit switch, preventing it from resetting properly. Consequently, the positioning management system misinterprets the nozzle as being locked, potentially leading to the nozzle detaching when the gantry rotates to 90° or 270°.

In response, Ion Beam Applications S.A. has implemented immediate and long-term corrective measures. Temporarily, all affected customers in regions including China, the United States, and South Korea were notified via a "Field Safety Notice," advising manual verification of nozzle locking before gantry rotation. Additionally, IBA service teams were instructed to inspect and clean the limit switch area and install visual verification markers. For a permanent solution, the company plans to update its maintenance protocols to include annual verification of the nozzle holder locking mechanism, ensuring enhanced patient safety and device integrity.