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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 ProteusONEsee related information
Date Initiated by FirmNovember 17, 2017
Create DateMarch 09, 2018
Recall Status1 Terminated 3 on June 14, 2021
Recall NumberZ-0938-2018
Recall Event ID 79230
510(K)NumberK101508 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductProteus 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 ContactSylviane 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
ActionOn 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 Commerce37
DistributionNationally
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LHN
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