FDA Device recall Z-1830-2017
Proteus 235, Proton Therapy System
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Proteus 235, Proton Therapy System by Ion Beam Applications, citing in specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1830-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-21 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | LA |
Product
Proteus 235, Proton Therapy System
Reason
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Identifiers
| code_info | Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0 |
|---|
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-1830-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.