China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. initiated a proactive, voluntary Class II recall of its proton therapy systems, as announced by the National Medical Products Administration (NMPA) on November 28, 2017. The recall addresses a critical safety concern regarding the system's handling of treatment plans involving multiple isocenters. The primary issue is the system's failure to automatically verify the consistency between manually entered center locations in the patient positioning system and the isocenter locations specified in the treatment plan. Users are required to manually input these differing center locations, but the system does not perform a check to ensure that the positional differences in the patient positioning system match those in the treatment plan. Consequently, if an incorrect center location is entered from the prescription, the system provides no notification to the user. This deficiency creates a risk of patient misalignment during proton therapy, especially when treating with multiple isocenters, unless users diligently follow the company's Clinical User Guide. This guide recommends manual verification of patient placement for each radiation field using X-ray images. The recall aims to mitigate potential deviations that could arise from this lack of automated cross-verification, ensuring patient safety within the NMPA's regulatory framework.