FDA Device recall Z-0938-2018
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with local…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with local… by Ion Beam Applications, citing there is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0938-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | n/a |
Product
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Identifiers
| code_info | PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.11…PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (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.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US) |
|---|
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-0938-2018%22
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