FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: IBA Proton Therapy System - PROTEUS 235
- Recall number
- Z-1497-2026
- Recalling firm
- Ion Beam Applications S.A.
- Product
- IBA Proton Therapy System - PROTEUS 235
- Status
- Open, Classified
- Initiated
- 2026-02-03
- Posted
- 2026-03-06
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 4 units (1 US, 3 OUS)
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- Lot, serial or model codes
- PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
- 510(k) numbers
- ["K163500"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3000256071
- Firm city
- Ottignies-Louvain-La-Neuve
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28