China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A., in conjunction with its Chinese affiliate, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., initiated a Class II voluntary recall of its Proton Therapy System, as published by the National Medical Products Administration (NMPA) on April 21, 2017. The recall addresses a significant safety concern where the system's rotating gantry could activate even when the treatment nozzle was not securely fastened. The root cause was identified as metal shavings accumulating near a limit switch in the nozzle's locking mechanism. This obstruction prevented the switch from resetting correctly, causing the system to erroneously interpret the nozzle as locked. This malfunction led to instances of nozzle detachment during gantry rotation at 90° and 270°. As immediate corrective measures, all affected customers in China received a "Field Safety Notice." Users are advised to visually confirm the nozzle is securely locked before initiating gantry rotation. Additionally, IBA's customer service teams are inspecting and cleaning limit switch locking rings, removing metal filings, and affixing visual markers for verification. For a long-term solution, Ion Beam Applications S.A. plans to update maintenance schedules to include annual verification of the nozzle holder locking mechanism.