FDA Device recall Z-2434-2021
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept…
- FDA Device
- Class II
- ongoing
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class II recall of Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept… by Ion Beam Applications, citing users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2434-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-14 |
| Published | 2021-09-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
Product
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Reason
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Identifiers
| code_info | PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116…PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (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-2434-2021%22
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