CLASS II Device recall · Reported 28 Jun 2017 · FDA Enforcement Report
Proteus recalled by Ion Beam Applications
Ion Beam Applications is recalling Proteus 235, distributed in 10 states. The recall was initiated on 9 Feb 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-2592-2017
- FDA event ID
- 77175
- Recalling firm
- Ion Beam Applications, Louvain La Neuve
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2017
- FDA classified
- 19 Jun 2017
- Reported
- 28 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2017 | Recall initiated by company | |
| 19 Jun 2017 | Classified by FDA | +130 days |
| 28 Jun 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
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Product as listed by the FDA
Proteus 235
Where it was distributed
Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
FloridaIllinoisLouisianaMassachusettsNew JerseyPennsylvaniaTennesseeTexasVirginiaWashington
Questions about this recall
Is Proteus 235 recalled?
Yes. Ion Beam Applications recalled Proteus 235 on 9 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-2592-2017.
Why was it recalled?
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Which lots are affected?
Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126
Where was it sold?
Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
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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