China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A., through its Chinese unit Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., initiated a Class II voluntary recall for its Proteus 235 Proton Therapy System. This action, reported to the National Medical Products Administration (NMPA) on March 22, 2017, addressed a critical safety concern where the system's rotating gantry could operate even when the nozzle was not properly secured. The root cause was identified as metal shavings accumulating within the nozzle's locking mechanism, which prevented the limit switch from resetting. This led the position management system to falsely register the nozzle as locked, resulting in nozzle detachment when the gantry rotated to 90° and 270°.

Immediate corrective actions included notifying affected customers in China via