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

Lot, batch or date codesPAT.115, SAT.116

Quantity recalled3

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

Washington

Questions about this recall

Is Proteus 235, graphite block 8 recalled?

Yes. Ion Beam Applications recalled Proteus 235, graphite block 8 on 17 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0930-2018.

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?

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
18 Mar 2026Device	CLASS II	IBA Proton Therapy System - Proteus recalled by Ion Beam Applications	Ion Beam Applications	Lead & Heavy Metals	Nationwide
18 Sep 2024Device	CLASS II	IBA Proton Therapy System - Proteus 235 ProteusPLUS and ProteusONE recalled	Ion Beam Applications	Device Malfunction	Nationwide
28 Aug 2024Device	CLASS II	IBA Proton Therapy System - Proteus 235- Designed to recalled	Ion Beam Applications	Other	9 states
12 Jun 2024Device	CLASS II	IBA Proton Therapy System - Proteus recalled by Ion Beam Applications	Ion Beam Applications	Other	Nationwide
1 May 2024Device	CLASS II	Iba Proton Therapy System - Proteus 235, Pts-10 versions recalled	Ion Beam Applications	Other	Nationwide

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