Proteus235- Proton Therapy System: to produce and deliver a proton… — Class II medical device recall Z-1205-2022
Ongoing recall by Ion Beam Applications S.A., reported 2022-06-08, distributed nationwide. First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoi
| Recall number | Z-1205-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain-la-neuve, N/A, Belgium |
| Recall initiated | 2022-04-20 |
| Classified | 2022-05-27 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 05404013801138 |
| Serial numbers | PAT108 |
Product
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Reason for recall
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
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-1205-2022. 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.