FDA Device recall Z-0020-2015
Proteus 235 Proton Therapy System for cancer treatment
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Proteus 235 Proton Therapy System for cancer treatment by Ion Beam Applications, citing while the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between tw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0020-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-27 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
Product
Proteus 235 Proton Therapy System for cancer treatment.
Reason
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Identifiers
| code_info | PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ion Beam Applications
- IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2026-03-18 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and…
FDA Device · Class II · 2024-09-18 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-08-28 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-06-12 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Device · Class II · 2024-05-01 · Ion Beam Applications
All Ion Beam Applications recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0020-2015%22
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