China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. initiated a Class II voluntary recall of its Proteus 235 Proton Therapy System, as reported to the National Medical Products Administration (NMPA) on March 22, 2017, and published on April 21, 2017. The recall was prompted by a critical safety issue where the system's rotating gantry could operate even when the treatment nozzle was not securely locked. This malfunction stemmed from metal shavings accumulating within the nozzle's locking mechanism, specifically around the limit switch. These shavings interfered with the switch's reset function, causing the system to erroneously detect the nozzle as locked when the positioning pin was not fully engaged. The severe consequence of this defect was nozzle detachment during gantry rotation, observed at 90° and 270° angles. The regulatory framework for this recall is under the NMPA. Affected regions included China, the United States, South Korea, France, and Germany. As immediate corrective actions, Ion Beam Applications S.A. issued "Field Safety Notices" to Chinese customers. Users were advised to meticulously verify the nozzle's secure locking before gantry rotation. Furthermore, the company’s customer service teams were instructed to inspect and clean limit switch locking rings and affix visual verification markers. For a long-term resolution, Ion Beam Applications S.A. plans to update maintenance protocols to include annual verification of the nozzle holder locking mechanism, ensuring enhanced patient safety and system reliability.