CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report
Proteus 235, Version Pts-11.0.1.2 and Pts-11.0.2 Product Usage recalled
Ion Beam Applications is recalling Proteus 235, Version Pts-11.0.1.2 and Pts-11.0.2 Product Usage: A, distributed nationwide in the US. The recall was initiated on 16 May 2018 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-2424-2018
- FDA event ID
- 80298
- Recalling firm
- Ion Beam Applications, Louvain La Neuve
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2018
- FDA classified
- 11 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 May 2018 | Recall initiated by company | |
| 11 Jul 2018 | Classified by FDA | +56 days |
| 18 Jul 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Product as listed by the FDA
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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
Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Questions about this recall
Why was it recalled?
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Which lots are affected?
Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
Where was it sold?
Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
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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