Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS and ProteusONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ProteusPLUS and ProteusONE see related information
Date Initiated by Firm May 16, 2018
Date Posted June 20, 2018
Recall Status1 Terminated 3 on October 16, 2018
Recall Number Z-2424-2018
Recall Event ID 80298
510(K)Number K101508  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2

Product Usage:
A 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.
Code Information Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
FDA Determined
Cause 2		 Software design
Action On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: vigiliance@iba-group.com
Quantity in Commerce 3 units
Distribution Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
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.
-
-