FDA Device recall Z-2592-2017
Proteus 235
- FDA Device
- Class II
- terminated
- Published 2017-06-28
On 2017-06-28 the FDA classified a Class II recall of Proteus 235 by Ion Beam Applications, citing it has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scannin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2592-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-09 |
| Published | 2017-06-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, IL, LA, MA, NJ, PA, TN, TX, VA, WA |
Product
Proteus 235
Reason
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Identifiers
| code_info | Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.1…Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 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-2592-2017%22
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