China NMPA Product Recall - Proton therapy system

On November 29, 2017, the National Medical Products Administration (NMPA) published a Level II proactive recall initiated by Ion Beam Applications S.A. (IBA) for its Proton Therapy Systems (Registration No. 国药管械（进）2003第3320636号). The recall addresses a critical safety concern regarding patient positioning during multi-isocenter treatment plans. The primary issue identified is that the proton therapy system fails to automatically verify the consistency between manually entered center locations in the patient positioning system and the isocenter locations specified in the treatment plan. This means users are not alerted if there's a discrepancy between these crucial coordinates. Consequently, if the patient positioning system's center location is incorrectly entered and the user does not perform manual verification with X-ray imaging, as recommended in IBA's Clinical User Guide, there is a risk of patient positioning errors. To mitigate this, IBA is undertaking several required actions. The company is distributing an "Emergency Field Safety Notice" to affected customers in China. This notice instructs users to diligently ensure that the differences in center positions entered into the patient positioning system match the corresponding differences in isocenter positions from the treatment plan. Furthermore, IBA will implement a software enhancement to automatically perform this consistency check. Should any mismatch be detected by the system, it will generate a warning notification for the user, thereby enhancing patient safety and treatment accuracy across affected regions including the USA, China, South Korea, France, Germany, Italy, Sweden, Netherlands, Czech Republic, and Poland.