Proteus 235 — Class II medical device recall Z-2684-2017
Terminated recall by Ion Beam Applications S.A., reported 2017-07-12, distributed in FL, IL, NJ, VA, WA. Software issue
| Recall number | Z-2684-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain La Neuve, N/A, Belgium |
| Recall initiated | 2016-12-13 |
| Classified | 2017-07-04 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2019-04-12 |
| Distributed | FL, IL, NJ, VA, WA |
| Countries outside the US | KR |
| Quantity | 6 worldwide |
| Reason classes | software |
| Serial numbers | PAT.003, PAT.006, PAT.108, PAT.112, PAT.113, SAT.116 |
Product
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason for recall
Software issue
Machine access
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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.