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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus 235

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  Class 2 Device Recall Proteus 235 see related information
Date Initiated by Firm July 17, 2020
Create Date July 27, 2020
Recall Status1 Terminated 3 on August 30, 2021
Recall Number Z-2715-2020
Recall Event ID 86076
510(K)Number K163500  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235
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.
Code Information Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Louvain-la-neuve Belgium
Manufacturer Reason
for Recall		 IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction notification will be communicated to all impacted IBA customers (users of the device), starting July 23, 2020. This letter instructs the customer: If this situation were to occur, it is recommended to complete the aborted treatment in Standalone Mode (please refer to the steps described in annex I and to the part Using adaPTdeliver in Standalone Mode of the Proton Therapy System Clinical Users Guide). IBA will modify the software to remove conditions that make impossible to load the plan to complete the aborted treatment. The solution will be deployed on your site by June 30, 2022.
Quantity in Commerce 2 Units
Distribution US: VA OUS: Belgium
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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