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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 June 27, 2018
Create Date July 17, 2018
Recall Status1 Terminated 3 on May 20, 2020
Recall Number Z-2470-2018
Recall Event ID 80384
510(K)Number K060695  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL

Product Usage:
Device is designed to produce and deliver 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.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.113, PAT.114, PAT.115, PAT.116, PAT.120, PAT.126, and PAT.132.
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Louvain-la-neuve Belgium
Manufacturer Reason
for Recall		 Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
FDA Determined
Cause 2		 Device Design
Action Recall was initiated on 6/27/18. Firm plans to provide the Urgent Medical Device Correction notifications to IBA site managers present on customer sites. The site managers will deliver the notification to customers by hand or email. The recall letter alerts users to the potential issue and instructs users to verify that apertures and accessories are fully inserted with both sides in the guide. The firm plans to deploy a solution on or before May 31, 2019, that will prevent occurrences of the issue.
Quantity in Commerce 14
Distribution US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
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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