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

Proteus 235 and Proteus ONE proton therapy systems recalled

Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems, distributed in 10 states. The recall was initiated on 18 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126

Quantity recalled18 worldwide and 10, 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-2672-2017
FDA event ID: 77620
Recalling firm: Ion Beam Applications, Louvain La Neuve, N/A
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2016
FDA classified: 3 Jul 2017
Reported: 12 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 May 2016	Recall initiated by company
3 Jul 2017	Classified by FDA	+411 days
12 Jul 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

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

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 and Proteus ONE proton therapy systems

Where it was distributed

Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

Florida Illinois Louisiana New Jersey Oklahoma Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

Which lots are affected?

Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126

Where was it sold?

Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, 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 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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