FDA Device recall Z-1603-2024
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions by Ion Beam Applications, citing there is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1603-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
Product
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Reason
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Identifiers
| code_info | PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.13…PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2024%22
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