China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA), through its Chinese responsible unit Ebia (Beijing) Particle Accelerator Technology Co., Ltd., initiated a Class II voluntary recall of its Proteus 235 Proton Therapy System. This recall, reported to the National Medical Products Administration (NMPA) on April 24, 2017, addresses a critical safety issue. The primary concern is that the system's rotating gantry can operate even when the treatment nozzle is not securely locked, posing a significant patient safety risk. The root cause identified involves metal shavings accumulating on the inner wall of a recess, which obstructs a limit switch crucial for confirming the nozzle's locked position. This obstruction leads the positioning management system to erroneously interpret the switch signal, falsely indicating that the nozzle is secured. Consequently, the gantry is permitted to rotate, potentially causing the nozzle to detach when the gantry reaches 900 or 2700. As required actions, IBA issued a "Site Safety Notice" to all affected Chinese customers. Temporary measures include instructing users to ensure the nozzle is fully aligned and the locking ring is tightened before gantry rotation, and for service teams to inspect and clear any metal obstructions from the limit switch, attaching tags to verify correct locking. Long-term corrective actions are planned to permanently resolve this mechanism malfunction.