China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA) initiated a proactive Level II recall of its Proton Therapy Systems (various models including Proteus 235), as reported by the National Medical Products Administration (NMPA) on November 29, 2017. The recall stems from a critical software deficiency concerning patient positioning when creating or importing treatment plans with multiple isocenters. The primary issue is that the proton therapy system fails to verify the consistency between manually entered center locations in the patient positioning system and the actual isocenter locations specified in the treatment plan. If there's a discrepancy in the prescription's patient positioning system center, the user receives no automatic notification. This lack of automated checking introduces a risk of patient placement deviation, particularly if users do not independently verify patient positioning for each radiation field using X-ray images, as recommended in IBA's Clinical User Guide. In response to this significant safety concern, IBA has outlined immediate and corrective actions. Temporarily, IBA will issue an "Emergency Field Safety Notice" to affected customers in China and other global regions, instructing users to meticulously ensure manual consistency between patient positioning system center differences and treatment plan isocenter differences. Furthermore, IBA commits to implementing a software update that will introduce an automated consistency check. This update will empower the proton therapy system to detect any mismatch between these crucial positional parameters and generate a warning for the user, thereby enhancing patient safety.