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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusONE

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  Class 2 Device Recall ProteusONE see related information
Date Initiated by Firm December 12, 2018
Create Date January 08, 2019
Recall Status1 Terminated 3 on April 15, 2020
Recall Number Z-0698-2019
Recall Event ID 81807
510(K)Number K091629  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235

Product Usage:
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 SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Louvain-la-neuve Belgium
Manufacturer Reason
for Recall		 There is a risk of detachment of the Compact Gantry Rolling Floor.
FDA Determined
Cause 2		 Device Design
Action On December 12, 2018, the firm notified its customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the product issue. Customers were reminded that nobody should stand on the rolling floor when the gantry is rotating, as specified in the Clinical User Guide. The recalling firm stated they would take the following actions: Short-term action: IBA will replace the rod end bearings attaching the cGRF to the nozzle via a preventive maintenance on all ProteusONE sites. Long-term action: A new design of the anchoring system of the cGRF to the nozzle will be deployed on all impacted sites via an upgrade kit by end of October 2019. Customers with questions should contact Sylviane BERGER Vigilance@iba-group.com +32 10 203 787, or Helpdesk +32 2 507 20 81 (available 24/7)
Quantity in Commerce 7
Distribution Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
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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