CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report

Proteus 235 The Proton Therapy System - Proteus recalled

Ion Beam Applications is recalling Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and, distributed nationwide in the US. The recall was initiated on 21 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 SBF.113 (US): manufactured June 2019 SBF.117 (EU): manufactured November 2019

Quantity recalled4 units

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-2773-2020
FDA event ID: 86073
Recalling firm: Ion Beam Applications, Louvain-la-neuve, N/A
Classification: Class II
Status: Terminated
Recall initiated: 21 Apr 2020
FDA classified: 7 Aug 2020
Reported: 19 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 Apr 2020	Recall initiated by company
7 Aug 2020	Classified by FDA	+108 days
19 Aug 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.

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 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.

Nationwide Florida Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 SBF.113 (US): manufactured June 2019 SBF.117 (EU): manufactured November 2019

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.

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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