The Proton Therapy System — Class II medical device recall Z-2284-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-07-04, distributed in FL. IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the
| Recall number | Z-2284-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Ion Beam Applications S.A., Louvain La Neuve, Belgium |
| Recall initiated | 2016-04-11 |
| Classified | 2018-06-23 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-03-25 |
| Distributed | FL |
| Countries outside the US | KR |
| Quantity | 2 |
| Reason classes | software |
Product
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Reason for recall
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2284-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.