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U.S. Department of Health and Human Services

Class 2 Device Recall The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)

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  Class 2 Device Recall The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE) see related information
Date Initiated by Firm April 11, 2016
Create Date June 23, 2018
Recall Status1 Terminated 3 on March 25, 2020
Recall Number Z-2284-2018
Recall Event ID 80217
510(K)Number K152224  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)

Proteus 235, Beam Management System (PBS)
Code Information PAT.003 and PAT.006
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.
Quantity in Commerce 2
Distribution Units were distributed to Korea and Jacksonville, FL.
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.
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