China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA) initiated a Class II voluntary recall for its Proton Therapy System, specifically the Proteus 235 model. This recall, reported on March 22, 2017, and published by the National Medical Products Administration (NMPA) on March 31, 2017, addresses a significant safety concern. The primary issue involves the rotating gantry of the proton therapy system, which could rotate even when the treatment nozzle was not properly secured. This critical defect stemmed from metal shavings accumulating on the inner wall of the recess, preventing a crucial limit switch from resetting. Consequently, the positioning management system misinterpreted the switch signal, falsely indicating the nozzle was locked. This malfunction presented a risk of the nozzle detaching when the gantry rotated to 90° and 270°. The affected products were distributed in several countries, including the United States, South Korea, France, Germany, and China. In response, IBA implemented both immediate and long-term corrective actions. Immediately, all affected customers received a "Field Safety Notice," advising users to manually verify the nozzle's secure locking before initiating gantry rotation. IBA's customer service teams were also dispatched to inspect limit switch locking rings, remove obstructing metal filings, and affix visual markers for easier verification. For a long-term resolution, IBA committed to updating its maintenance plan to incorporate annual verification of the nozzle holder locking mechanism.