China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA) initiated a Class II voluntary recall of its proton therapy systems, as reported to the National Medical Products Administration (NMPA) on March 22, 2017, with a publication date of March 31, 2017. The recall, impacting device registration number SDA(I) 20033320636, stemmed from a critical safety issue where the rotating gantry of the proton therapy system could rotate even when the nozzle was not properly locked. The root cause was identified as metal shavings accumulating on the inner wall of the recess, preventing a crucial limit switch from resetting. This misleads the positioning management system into believing the nozzle's locating pin is secured, allowing gantry rotation and leading to potential nozzle detachment when the gantry moves to 90° and 270°. Affected regions include China, the United States, South Korea, France, and Germany, involving Proteus 235 models. Immediate corrective actions included notifying Chinese customers via a "Field Safety Notice," advising manual nozzle lock verification, and directing IBA customer service to inspect and clean limit switches, adding visual verification markers. A long-term measure involves updating maintenance plans to include annual verification of the nozzle holder locking mechanism.