CLASS II Device recall · Reported 12 Jul 2017 · FDA Enforcement Report

Proteus 235, Proton Therapy System recalled by Ion Beam Applications

Ion Beam Applications is recalling Proteus 235, Proton Therapy System, distributed in Florida, Illinois, New Jersey, Virginia, Washington. The recall was initiated on 13 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

Quantity recalled6 worldwide and 5 in the U.S.

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-2684-2017
FDA event ID: 77621
Recalling firm: Ion Beam Applications, Louvain La Neuve, N/A
Classification: Class II
Status: Terminated
Recall initiated: 13 Dec 2016
FDA classified: 4 Jul 2017
Reported: 12 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Dec 2016	Recall initiated by company
4 Jul 2017	Classified by FDA	+203 days
12 Jul 2017	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

Software issue

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a 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

Distributed to FL, VA, IL, NJ, WA and South Korea

Florida Illinois New Jersey Virginia Washington

Questions about this recall

Why was it recalled?

Software issue

Which lots are affected?

Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

Where was it sold?

Distributed to FL, VA, IL, NJ, WA and South Korea

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
18 Mar 2026Device	CLASS II	IBA Proton Therapy System - Proteus recalled by Ion Beam Applications	Ion Beam Applications	Device Malfunction	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 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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