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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS, Proteus ONE

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  Class 2 Device Recall ProteusPLUS, Proteus ONE see related information
Date Initiated by Firm January 26, 2018
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-1477-2018
Recall Event ID 79605
510(K)Number K101508  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Code Information Affected version: PTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
FDA Determined
Cause 2		 Under Investigation by firm
Action On January 26, 2018, the firm sent Field Safety Notices to all its consignees by email or delivered personally, alerting them of the issue. The notice recommended that users not resume pauses in Uniform Scanning more than twice without informing on-site firm personnel. The firm also recommended rebooting the Scanning Magnets Power Supply Electronic Unit if the issue occurs. The recalling firm stated it would implement an upgrade of the Scanning Magnet Power Supply Electronic Unit at all affected sites by June 30, 2018. Consignees were instructed to sign and return a copy of a notice read confirmation within 10 working days. Recalling firm Helpdesk Contact: +32 2 507 20 81 (available 24/7)
Quantity in Commerce 5
Distribution Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.
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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