FDA Device recall Z-0747-2022
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other con…
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other con… by Ion Beam Applications, citing when resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0747-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-15 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, IL, KS, LA, MI, NJ, OK, PA, TN, TX, VA, WA |
Product
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Reason
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Identifiers
| code_info | PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113…PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Ion Beam Applications
- IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2026-03-18 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and…
FDA Device · Class II · 2024-09-18 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-08-28 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-06-12 · Ion Beam Applications - IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Device · Class II · 2024-05-01 · Ion Beam Applications
All Ion Beam Applications recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0747-2022%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.