Recall Z-1497-2026— Ion Beam Applications S.A.

Name: FDA recall Z-1497-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-03

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2026-02-03. It names one FDA 510(k) clearance: K163500. Product: IBA Proton Therapy System - PROTEUS 235. Reason: 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..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-03
Firm location: Ottignies-Louvain-La-Neuve, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A.·cleared 2017-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.