CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report
Proteus 235, Universal Nozzle with snout recalled
Ion Beam Applications is recalling Proteus 235, Universal Nozzle with snout ; PBS dedicated nozzle with snout XL, distributed nationwide in the US. The recall was initiated on 27 Jun 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-2470-2018
- FDA event ID
- 80384
- Recalling firm
- Ion Beam Applications, Louvain-la-neuve
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2018
- FDA classified
- 17 Jul 2018
- Reported
- 25 Jul 2018
- 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
| 27 Jun 2018 | Recall initiated by company | |
| 17 Jul 2018 | Classified by FDA | +20 days |
| 25 Jul 2018 | 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
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
Product as listed by the FDA
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Where it was distributed
US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
Nationwide FloridaNew JerseyOklahomaPennsylvaniaTexasVirginiaWashington
Questions about this recall
Why was it recalled?
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
Which lots are affected?
PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.113, PAT.114, PAT.115, PAT.116, PAT.120, PAT.126, and PAT.132.
Where was it sold?
US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
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 |
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