China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA) initiated a Class II voluntary recall of its Proteus 235 proton therapy systems, as detailed in a National Medical Products Administration (NMPA) document published on April 21, 2017, following a report dated March 22, 2017. The recall, reported by IBA's Chinese entity, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., addresses a critical safety concern. The primary issue is that the system's rotating gantry may operate even when the treatment nozzle is not securely locked. This dangerous malfunction stems from metal shavings accumulating within the nozzle locking mechanism, preventing a crucial limit switch from resetting. Consequently, the system's positioning management misinterprets an unlocked nozzle as secured, allowing gantry rotation. This defect has led to instances of nozzle detachment when the gantry rotated to 90° and 270°, posing significant patient safety risks. Under the NMPA regulatory framework, IBA has outlined immediate and long-term corrective actions. Temporary measures include issuing a "Field Safety Notice" to all affected customers, advising manual verification of nozzle locking before gantry rotation, and instructing service teams to inspect and clean limit switches while adding visual verification markers. For a long-term resolution, IBA plans to update maintenance protocols to incorporate annual verification of the nozzle holder locking mechanism, ensuring enhanced patient safety and system reliability.