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U.S. Department of Health and Human Services

Class 2 Device Recall IBA

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 Class 2 Device Recall IBAsee related information
Date Initiated by FirmMay 10, 2024
Date PostedJune 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1945-2024
Recall Event ID 94576
510(K)NumberK163500 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductIBA Proton Therapy System - PROTEUS 235 - 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 UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator
FEI Number 3000256071
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Ottignies-Louvain-La-Neuve Belgium
For Additional Information ContactSAME
104758811
Manufacturer Reason
for Recall		Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
FDA Determined
Cause 2		Device Design
ActionIba issued Urgent Medical Device Correction Letter on May 10, 2024 via IBA responsible directly to customer site either by hand or by email. Letter states reason for recall, health risk and action to take: ACTION BEING TAKEN BY IBA Monitoring of the deflector, software upgrade. 7.2 CORRECTIVE ACTIONS Software upgrade 7.3 PREVENTIVE ACTIONS Waiting for the solution to be deployed, IBA will distribute an Internal User Notice to IBA operators of impacted sites with instructions to monitor the deflector and stop the irradiation when necessary. 7.4 TIME SCHEDULE FOR THE IMPLEMENTATION OF THE DIFFERENT ACTIONS The Internal User Notice will be provided to IBA operators by May 10, 2024. The corrective action will be implemented at your site by June 2025. Contact: Sonia PINEL Vigilance@iba-group.com
Quantity in Commerce2 units
DistributionWorldwide - US Nationwide distribution in the state of Virginia and the country of India.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHN
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