ProteusPLUS and ProteusONE- designed to produce and deliver a proton… — Class II medical device recall Z-0747-2022
Ongoing recall by Ion Beam Applications S.A., reported 2022-03-16, distributed in FL, IL, KS, LA, MI, NJ, OK, PA…. When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been
| Recall number | Z-0747-2022 |
|---|---|
| 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 | 2022-02-15 |
| Classified | 2022-03-10 |
| Reported by FDA | 2022-03-16 |
| Distributed | FL, IL, KS, LA, MI, NJ, OK, PA, TN, TX, VA, WA |
| Countries outside the US | BE, CZ, DE, ES, FR, GB, IT, KR, NL, PL, RU, SE, TW |
| UPC / GTIN / UDI-DI | 05404013801138 |
Product
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Reason for recall
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
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-0747-2022. 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.