CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
Proteus 235, graphite block recalled by Ion Beam Applications
Ion Beam Applications is recalling Proteus 235, graphite block 8, distributed in Washington. The recall was initiated on 17 Oct 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-0930-2018
- FDA event ID
- 79227
- Recalling firm
- Ion Beam Applications, Louvain La Neuve, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2017
- FDA classified
- 8 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2017 | Recall initiated by company | |
| 8 Mar 2018 | Classified by FDA | +142 days |
| 14 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
Product as listed by the FDA
Proteus 235, graphite block 8
Where it was distributed
WA
Questions about this recall
Why was it recalled?
IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
Which lots are affected?
PAT.115, SAT.116
Where was it sold?
WA
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
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