Summary
The FDA issued a Class II for IBA Proton Therapy System - PROTEUS 235 by Ion Beam Applications S.A.. Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, .
Details
Source
Device Recall
External ID
Z-1497-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
IBA Proton Therapy System - PROTEUS 235
Lot/Code Info: PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Quantity Affected: 4 units (1 US, 3 OUS)
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.
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-03
Company
Ottignies-Louvain-La-Neuve, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ion Beam Applications S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ion Beam Applications S.A. have FDA actions?
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1497-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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