Class II — Ion Beam Applications S.A.
| Recalling firm | ION BEAM APPLICATIONS S.A. |
|---|---|
| Registered facility | ION BEAM APPLICATIONS S.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. |
| Product | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System. |
| Quantity | 5 (US), 9 (OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan. |
| Initiated | 2023-09-18 |
| Classified | 2023-11-14 |
| Recall number | Z-0295-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ion Beam Applications S.A. (Z-0295-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93293/
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