FDA Device recall Z-2284-2018
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) by Ion Beam Applications, citing IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2284-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-11 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL |
Product
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Reason
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Identifiers
| code_info | PAT.003 and PAT.006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2284-2018%22
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