Proton Therapy System (IBA) – Positioning System Issue (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Recommended Action

Per FDA guidance

IBA isued Urgent Medical Device Correction letter on July 10, 2024. Letter states reason for recall, health risk and action to take: IBA would like to remind you as IBA Proton Therapy System -PROTEUS 235 user of the warnings present in your Clinical User's Guide which emphasize the importance of carefully monitoring the patients behavior during the different treatment phases. IBA would like to also remind you that the manual hand crank could be used by the system operator for the emergency release of the Patient Positioning System in the situations listed in the Clinical User's Guide and Accelerator Operator's Guide and by following the instructions described in both guides. To be signed and given back to IBA representative on site. PTS-8, PTS-10 and PTS-11 versions: Software upgrade IBA will update the software of the Positioning Management System in order that, after a collision, the request to temporarily disable the collision detection will be sent until the status of the collision detection is well disabled. This solution will be deployed at your site by March 2026. PTS-12 versions: users training and labeling change IBA will provide customer training on the system behavior in PTS-12 versions following collision detections. Additionally, IBA will update the labeling to clarify that users can also move the snout or gantry to go out collision situations. These solutions will be deployed at your site by January 2025

Distribution

As reported by FDA

IL, LA, MI, NJ, OK, TN, TX, VA, WA