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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPlus

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  Class 2 Device Recall ProteusPlus see related information
Date Initiated by Firm December 13, 2016
Create Date July 04, 2017
Recall Status1 Terminated 3 on April 12, 2019
Recall Number Z-2684-2017
Recall Event ID 77621
510(K)Number K152224  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Proton Therapy System

Product Usage:
The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Code Information Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 Software issue
FDA Determined
Cause 2		 Software design
Action An Urgent Field Safety Notice was mailed to affected customers to inform them of the issue. The notice indicated possible software failure, the associated risks and actions users should implement to correct the issue. IBA plans to follow-up with a software update which will be deployed on impacted sites to correct this issue.
Quantity in Commerce 6 worldwide and 5 in the U.S.
Distribution Distributed to FL, VA, IL, NJ, WA and South Korea
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 = LHN and Original Applicant = ION BEAM APPLICATION S.A.
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