FDA Device recall Z-2715-2020
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and…
- FDA Device
- Class II
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and… by Ion Beam Applications, citing IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2715-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-17 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ion Beam Applications |
| Distribution | VA |
Product
Proteus 235 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.
Reason
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Identifiers
| code_info | Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 |
|---|
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-2715-2020%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.