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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus Plus

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  Class 2 Device Recall Proteus Plus see related information
Date Initiated by Firm March 21, 2017
Create Date April 17, 2017
Recall Status1 Terminated 3 on September 19, 2018
Recall Number Z-1830-2017
Recall Event ID 76804
510(K)Number K152224  
Product Classification radiation therapy system - Product Code LHN
Product Proteus 235, Proton Therapy System
Code Information Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS- and PTS-9.4.0
Recalling Firm/
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
FDA Determined
Cause 2
Software design
Action A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.
Quantity in Commerce 2 worldwide, 1 in U.S.
Distribution Distribution in US (to Louisiana), and France.
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.