CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report
Proteus 235 The Proton Therapy System - Proteus recalled
Ion Beam Applications is recalling Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and, distributed in Virginia. The recall was initiated on 17 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2715-2020
- FDA event ID
- 86076
- Recalling firm
- Ion Beam Applications, Louvain-la-neuve, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2020
- FDA classified
- 27 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2020 | Recall initiated by company | |
| 27 Jul 2020 | Classified by FDA | +10 days |
| 5 Aug 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Product as listed by the FDA
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.
Where it was distributed
US: VA OUS: Belgium
Questions about this recall
Why was it recalled?
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Which lots are affected?
Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
Where was it sold?
US: VA OUS: Belgium
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ion Beam Applications
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IBA Proton Therapy System - Proteus recalled by Ion Beam Applications | Ion Beam Applications | Device Malfunction | Nationwide |
| Device | CLASS II | IBA Proton Therapy System - Proteus 235 ProteusPLUS and ProteusONE recalled | Ion Beam Applications | Device Malfunction | Nationwide |
| Device | CLASS II | IBA Proton Therapy System - Proteus 235- Designed recalled | Ion Beam Applications | Other | 9 states |
| Device | CLASS II | IBA Proton Therapy System - Proteus recalled by Ion Beam Applications | Ion Beam Applications | Other | Nationwide |
| Device | CLASS II | Iba Proton Therapy System - Proteus 235, Pts-10 versions recalled | Ion Beam Applications | Other | Nationwide |
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