FDA Device recall Z-0295-2024
IBA Proton Therapy System - PROTEUS 235
- FDA Device
- Class II
- ongoing
- Published 2023-11-22
On 2023-11-22 the FDA classified a Class II recall of IBA Proton Therapy System - PROTEUS 235 by Ion Beam Applications, citing the patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0295-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-18 |
| Published | 2023-11-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
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.
Reason
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Identifiers
| code_info | UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT13…UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0295-2024%22
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