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U.S. Department of Health and Human Services

Class 2 Device Recall Beam Management System

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  Class 2 Device Recall Beam Management System see related information
Date Initiated by Firm October 19, 2017
Create Date March 08, 2018
Recall Status1 Terminated 3 on April 02, 2019
Recall Number Z-0931-2018
Recall Event ID 79228
510(K)Number K082416  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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 PAT.003 (KR), PAT.006 (US)
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
For Additional Information Contact US Agent
215-972-7985
Manufacturer Reason
for Recall		 Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
FDA Determined
Cause 2		 Device Design
Action IBA sent an Urgent Field Safety Notice dated October 19, 2017 , issued to customers stating the following: IBA recommends performing a check to detect the consequence of this potential power supply regulation issue on a regular basis (IBA recommends Monthly), see Annex 1 for details. IBA is developing a corrective action in order to reduce the hysteresis effect and detect magnet current overshoot. This solution will be deployed to all systems using JEMA analog power supply. This solution will be validated and deployed by April 2018. For further questions, please call (215) 972-7985
Quantity in Commerce 3
Distribution US Distribution to the state of :FL
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 APPLICATIONS S.A.
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