CLASS II ONGOING Device recall · Reported 8 Jun 2022 · FDA Enforcement Report
Proteus235- Proton Therapy System: to produce recalled
Ion Beam Applications is recalling Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment, distributed nationwide in the US. The recall was initiated on 20 Apr 2022 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-1205-2022
- FDA event ID
- 90213
- Recalling firm
- Ion Beam Applications, Louvain-la-neuve, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Apr 2022
- FDA classified
- 27 May 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Apr 2022 | Recall initiated by company | |
| 27 May 2022 | Classified by FDA | +37 days |
| 8 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Product as listed by the FDA
Proteus235- Proton Therapy System: 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 distribution in the states of IL, VA, WA and the country of Germany.
Questions about this recall
Why was it recalled?
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Which lots are affected?
UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
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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