CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report
IBA Proton Therapy System - Proteus recalled by Ion Beam Applications
Ion Beam Applications is recalling IBA Proton Therapy System - Proteus 235, distributed nationwide in the US. The recall was initiated on 18 Sep 2023 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-0295-2024
- FDA event ID
- 93293
- Recalling firm
- Ion Beam Applications, Ottignies-Louvain-La-Neuve, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Sep 2023
- FDA classified
- 14 Nov 2023
- Reported
- 22 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2023 | Recall initiated by company | |
| 14 Nov 2023 | Classified by FDA | +57 days |
| 22 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Product as listed by the FDA
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Where it was distributed
Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
Questions about this recall
Why was it recalled?
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Which lots are affected?
UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
Where was it sold?
Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
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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