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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus 235

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  Class 2 Device Recall Proteus 235 see related information
Date Initiated by Firm March 27, 2014
Date Posted October 29, 2014
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = ION BEAM APPLICATIONS S.A.