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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusONE

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 Class 2 Device Recall ProteusONEsee related information
Date Initiated by FirmFebruary 03, 2026
Date PostedMarch 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1497-2026
Recall Event ID 98364
510(K)NumberK163500 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductIBA Proton Therapy System - PROTEUS 235
Code Information PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
FEI Number 3000256071
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Ottignies-Louvain-La-Neuve Belgium
For Additional Information ContactInez Wathion
104758811
Manufacturer Reason
for Recall		It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
FDA Determined
Cause 2		Software design
ActionOn February 3, 2026 Urgent Medical Device Correction letters were sent to customers. Letter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.
Quantity in Commerce4 units (1 US, 3 OUS)
DistributionWorldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
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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