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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS

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  Class 2 Device Recall ProteusPLUS see related information
Date Initiated by Firm December 05, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0934-2018
Recall Event ID 79231
510(K)Number K060695  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Uniform and Pencil Beam Scanning

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 PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
For Additional Information Contact
215-972-7985
Manufacturer Reason
for Recall		 An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
FDA Determined
Cause 2		 Device Design
Action Ion Beam Applications (IBA) sent an Urgent Field Safety Notice dated December 5, 2017, to customers informing them of the issue and request that all users verify that the accessory is correctly inserted in snout 300x400 with both rails in the guide. A solution to this issue including a hardware modification will be deployed on or before March 31, 2018. For further questions, please call (215) 972-7985.
Quantity in Commerce 14
Distribution US Distribution to the states of : MA, FL, VA, PA, OK, TN
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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