CLASS II ONGOING Device recall · Reported 15 Sep 2021 · FDA Enforcement Report

Proteus 235- designed to produce recalled by Ion Beam Applications

Ion Beam Applications is recalling Proteus 235- designed to produce and deliver a proton beam for the treatment of patients, distributed nationwide in the US. The recall was initiated on 14 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).

Quantity recalled27 worldwide, 11 in 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-2434-2021
FDA event ID: 88449
Recalling firm: Ion Beam Applications, Louvain-la-neuve, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jun 2021
FDA classified: 10 Sep 2021
Reported: 15 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jun 2021	Recall initiated by company
10 Sep 2021	Classified by FDA	+88 days
15 Sep 2021	Published in enforcement report	+5 days

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

Reason for recall

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Product as listed by the FDA

Proteus 235- 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 in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.

Nationwide Florida Illinois Louisiana Michigan New Jersey Oklahoma Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Which lots are affected?

PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, 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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