FDA Device recall Z-0698-2019
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed…
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed… by Ion Beam Applications, citing there is a risk of detachment of the Compact Gantry Rolling Floor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0698-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-12 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
Product
Proteus 235 Product Usage: 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
There is a risk of detachment of the Compact Gantry Rolling Floor.
Identifiers
| code_info | SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0698-2019%22
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