Proteus 235-Proton Therapy System — Class II medical device recall Z-2155-2021
Ongoing recall by Ion Beam Applications S.A., reported 2021-08-04, distributed in FL, PA, TN, TX, VA. if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the
| Recall number | Z-2155-2021 |
|---|---|
| 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 | 2021-05-26 |
| Classified | 2021-07-28 |
| Reported by FDA | 2021-08-04 |
| Distributed | FL, PA, TN, TX, VA |
| Countries outside the US | DE, IN, IT, NL, RU, SE |
| Serial numbers | PAT.107 |
Product
Proteus 235-Proton Therapy System
Reason for recall
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
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-2155-2021. 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.