FDA Device recall Z-2155-2021
Proteus 235-Proton Therapy System
- FDA Device
- Class II
- ongoing
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of Proteus 235-Proton Therapy System by Ion Beam Applications, citing if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2155-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-26 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, PA, TN, TX, VA |
Product
Proteus 235-Proton Therapy System
Reason
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Identifiers
| code_info | Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.1…Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2155-2021%22
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