China NMPA Product Recall - Proton therapy system

Ion Beam Applications S.A. (IBA) initiated a Level II proactive recall of its Proton Therapy Systems, as documented by the National Medical Products Administration (NMPA) on November 29, 2017, with the recall report dated November 21, 2017. The recall affects various Proteus 235 models, including specific PAT, SAT, and SBF units, operating in regions including China, USA, South Korea, and several European countries.

The primary issue identified is a critical software deficiency in the proton therapy system. When creating or importing treatment plans involving multiple isocenters, users are required to manually input different center locations into the patient positioning system. The system fails to automatically verify the consistency between these manually entered patient positioning system coordinates and the actual isocenter locations specified in the treatment plan. Consequently, if an incorrect center location is entered, the system does not provide any notification or warning to the user, potentially leading to inaccurate radiation delivery. This deviation could occur particularly if users do not adhere to the recommended practice of verifying patient placement for each radiation field using X-ray images.

In response, IBA has implemented immediate corrective actions and outlined future system enhancements. Temporarily, an "Emergency Field Safety Notice" is being issued to affected customers, instructing them to manually ensure the precision and consistency between the patient positioning system's center coordinates and the treatment plan's isocenter coordinates. Furthermore, IBA is developing a software update to integrate an automated consistency check. This update will enable the proton therapy system to proactively identify and alert users to any discrepancies between these critical positional data points, thereby mitigating the risk of incorrect patient treatment.