FDA Device recall Z-0934-2018
Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medi…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medi… by Ion Beam Applications, citing an accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0934-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-05 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, MA, OK, PA, TN, VA |
Product
Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Identifiers
| code_info | PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (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-0934-2018%22
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