IBA Proton Therapy System - PROTEUS 235
FDA device recall Z-1497-2026 · posted 2026-03-06 · Open, Classified
Recall details
- Recalling firm
- Ion Beam Applications S.A.
- 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.
- Action taken
- On 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LHN
- Quantity affected
- 4 units (1 US, 3 OUS)
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- Date initiated
- 2026-02-03
- Date posted
- 2026-03-06
- Location
- Ottignies-Louvain-La-Neuve, Belgium
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (K163500) | Ion Beam Applications S.A. | 2017-08-17 |