FDA Device recall Z-1205-2022
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other condi…
- FDA Device
- Class II
- ongoing
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other condi… by Ion Beam Applications, citing first layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1205-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-20 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
Product
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Reason
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Identifiers
| code_info | UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU). |
|---|
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-1205-2022%22
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