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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus Plus and Proteus ONE

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  Class 2 Device Recall Proteus Plus and Proteus ONE see related information
Date Initiated by Firm February 09, 2017
Date Posted June 19, 2017
Recall Status1 Terminated 3 on July 14, 2023
Recall Number Z-2592-2017
Recall Event ID 77175
510(K)Number K152224  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235
Code Information Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126
Recalling Firm/
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
For Additional Information Contact
Manufacturer Reason
for Recall
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
FDA Determined
Cause 2
Device Design
Action Ion Beam Application S.A. (IBA) will bring the defect into compliance: 1. Providing recommendations for user actions which, if followed, will prevent dark current. In order to prevent the error from occurring, the IBA customers are provided with a specific QA map that would detect dark current and instructions on how and when to use it (Annex 1). This guidance was included in IBAs User Notice which was sent to users on February 9, 2017. 2. IBA is developing a long term solution consisting of a new IC-cyclo (ionization chamber located at the cyclotron exit) and a Beam Absence Electronic Unit (BAEU) along with a software upgrade. This solution will detect presence of dark current between irradiations. It will prevent starting a new irradiation if dark current is present. This solution is currently in test phase and will be completed in two years. 3. Manufacturer will provide the FDA with progress reports on the effectiveness of the plan, including the number of electronic products repaired on a quarterly basis. The first progress report will be provided to the FDA by September 15, 2017 to the correspondence identified below. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions please call (571) 449-4992.
Quantity in Commerce 18 systems ( 10 in the US)
Distribution Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
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 APPLICATION S.A.