Z-1497-2026 Class II Ongoing
FDA device recall Z-1497-2026 was initiated by Ion Beam Applications S.A. on February 3, 2026 and is designated Class II. 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 th… The recall status is ongoing. Affected quantity: 4 units (1 US, 3 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2026
- Initiation Date
- February 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units (1 US, 3 OUS)
Product Description
IBA Proton Therapy System - PROTEUS 235
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 Pattern
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Code Information
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)