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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus One, Proteus Plus

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  Class 2 Device Recall Proteus One, Proteus Plus see related information
Date Initiated by Firm April 10, 2017
Date Posted May 03, 2017
Recall Status1 Terminated 3 on February 16, 2018
Recall Number Z-2097-2017
Recall Event ID 76977
510(K)Number K152224  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proton therapy system -Proteus 235 aka Proteus Plus.

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.
Code Information Serial numbers: PAT.003, PAT.006 
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
FDA Determined
Cause 2		 Software design
Action Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.
Quantity in Commerce 2
Distribution 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 APPLICATION S.A.
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