CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Proteus recalled by Ion Beam Applications
Ion Beam Applications is recalling Proteus 235, distributed in Florida, Massachusetts, Tennessee, Virginia. The recall was initiated on 9 Mar 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-1695-2017
- FDA event ID
- 76696
- Recalling firm
- Ion Beam Applications, Louvain La Neuve
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2017
- FDA classified
- 29 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Mar 2017 | Recall initiated by company | |
| 29 Mar 2017 | Classified by FDA | +20 days |
| 5 Apr 2017 | 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
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Product as listed by the FDA
Proteus 235
Where it was distributed
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Questions about this recall
Is Proteus 235 recalled?
Yes. Ion Beam Applications recalled Proteus 235 on 9 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1695-2017.
Why was it recalled?
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Which lots are affected?
Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
Where was it sold?
Distributed in MA, FL, VA, and TN. China, South Korea, France and 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 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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