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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS and ProteusONE

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  Class 2 Device Recall ProteusPLUS and ProteusONE see related information
Date Initiated by Firm November 17, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on June 14, 2021
Recall Number Z-0938-2018
Recall Event ID 79230
510(K)Number K101508  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Code Information PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
For Additional Information Contact Sylviane Berger
571-4494992
Manufacturer Reason
for Recall		 There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
FDA Determined
Cause 2		 Device Design
Action On November 17, 2017 an Urgent Field Safety Notice was issued to customers informing users that when creating or importing a treatment plan with multiple isocenters, the user has to enter Patient Positioning System positions manually.
Quantity in Commerce 37
Distribution Nationally
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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