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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusONE

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  Class 2 Device Recall ProteusONE see related information
Date Initiated by Firm November 01, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0943-2018
Recall Event ID 79229
510(K)Number K152224  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1

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 SBF.101 (EU), SBF.105 (US)
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
FDA Determined
Cause 2		 Device Design
Action The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system will be deployed on February 28, 2017. If you have any questions, contact Customer Complaints & Vigilance Director at Vigilance@iba-group.com or +32 10 203 787 or helpdesk at +32 2 507 20 81 (available 24/7).
Quantity in Commerce 3
Distribution Worldwide Distribution: US (nationwide) to: MI only and country of: France.
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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