CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Proteus 235, Proton Therapy System recalled by Ion Beam Applications
Ion Beam Applications is recalling Proteus 235, Proton Therapy System, distributed in Louisiana. The recall was initiated on 21 Mar 2017 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-1830-2017
- FDA event ID
- 76804
- Recalling firm
- Ion Beam Applications, Louvain La Neuve, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2017
- FDA classified
- 17 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Mar 2017 | Recall initiated by company | |
| 17 Apr 2017 | Classified by FDA | +27 days |
| 26 Apr 2017 | 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
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Product as listed by the FDA
Proteus 235, Proton Therapy System
Where it was distributed
Distribution in US (to Louisiana), and France.
Questions about this recall
Is Proteus 235, Proton Therapy System recalled?
Yes. Ion Beam Applications recalled Proteus 235, Proton Therapy System on 21 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1830-2017.
Why was it recalled?
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Which lots are affected?
Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
Where was it sold?
Distribution in US (to Louisiana), and France.
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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