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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 October 17, 2017
Create Date March 08, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0930-2018
Recall Event ID 79227
510(K)Number K101508  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, graphite block 8
Code Information PAT.115, SAT.116
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
FDA Determined
Cause 2		 Component design/selection
Action On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak.
Quantity in Commerce 3
Distribution WA
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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