CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report
The Proton Therapy System - Proteus 235 (brand names recalled
Ion Beam Applications is recalling The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE), distributed in Florida. The recall was initiated on 11 Apr 2016 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-2284-2018
- FDA event ID
- 80217
- Recalling firm
- Ion Beam Applications, Louvain La Neuve
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2016
- FDA classified
- 23 Jun 2018
- Reported
- 4 Jul 2018
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Apr 2016 | Recall initiated by company | |
| 23 Jun 2018 | Classified by FDA | +803 days |
| 4 Jul 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Where it was distributed
Units were distributed to Korea and Jacksonville, FL.
Questions about this recall
Is The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) recalled?
Yes. Ion Beam Applications recalled The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) on 11 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2284-2018.
Why was it recalled?
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Which lots are affected?
PAT.003 and PAT.006
Where was it sold?
Units were distributed to Korea and Jacksonville, FL.
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 21 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 | Lead & Heavy Metals | 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 to 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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