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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS

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 Class 2 Device Recall ProteusPLUSsee related information
Date Initiated by FirmNovember 29, 2021
Create DateJanuary 07, 2022
Recall Status1 Terminated 3 on February 20, 2024
Recall NumberZ-0466-2022
Recall Event ID 89267
510(K)NumberK163500 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductProteus 235; Version: PTS-8 versions before PTS-8.7.2
Code Information PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
FEI Number 3000256071
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Louvain-la-neuve Belgium
For Additional Information ContactSylviane Berger
32-478 887 029
Manufacturer Reason
for Recall		Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
FDA Determined
Cause 2		Device Design
ActionA Urgent Medical Device Correction notification, Ref: IBA PR-121508, was communicated to all impacted IBA customers (users of the device) on Dec 6, 2021. Action to be taken by user: 1. Please transfer this notice to other organizations on which this action has an impact. 2. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 3. Please return the copy of the Urgent Medical Device Correction signed to IBA within 10 working days. Action by IBA: 1. IBA will upgrade the PTS version of each impacted site to a PTS version equal or superior to PTS-8.7.2. The PTS version upgrade will be deployed on your site by August 2022. 2. From PTS-8.7.2, the startup of the PTS software in the clinical environment is blocked if the shutdown of any process running in the test environment has not been successful. A message is displayed to request IBA operator to manually stop the remaining processes running in the test environment. Until the solution is implemented on your site, IBA operation team will ensure that any process running in the test environment is correctly shut down before each startup of the PTS in the clinical environment. for any question, contact Sylviane BERGER, Vigilance@iba-group.com, +32 10 203 787 or helpdesk +32 2 507 20 81 (available 24/7.
Quantity in Commerce5 devices
DistributionIN USA: VA, OK, NJ, TN OUS: Czech Republic.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LHN
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