FDA Device recall Z-1695-2017
Proteus 235
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Proteus 235 by Ion Beam Applications, citing the Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1695-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-09 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, MA, TN, VA |
Product
Proteus 235
Reason
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Identifiers
| code_info | Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120 |
|---|
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-1695-2017%22
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