Class 2 Device Recall Proteus 235

• Date Initiated by Firm: March 27, 2014
• Date Posted: October 29, 2014
• Recall Status: Terminated on December 10, 2014
• Recall Number: Z-0020-2015
• Recall Event ID: 68846
• 510(K)Number: K082416
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Proteus 235 Proton Therapy System for cancer treatment.
• Code Information: PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin du Cyclotron, 3; Louvain La Neuve Belgium
• Manufacturer Reason for Recall: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
• FDA Determined Cause: Device Design
• Action: A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.
• Quantity in Commerce: 8
• Distribution: Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE