ProteusPLUS and ProteusONE- designed to produce and deliver… recallZ-0747-2022 · Ion Beam Applications S.A. · initiated Feb 15, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Ion Beam Applications S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

FDA root cause category: Device Design

What the company is doing

IBA issued Urgent Medical Device Correction notification on February 15, 2022 directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take: For Proton Therapy sites where the system is operated by the customer: - Warn operators to not manually change the beam range (action called manual set range ) while a patient is on the Patient Positioning System. - IBA will provide a training to all operators about the correct use of the action called manual set range and the risk associated to its use while a patient is on the Patient Positioning System. This training will be provided on your site by August 31, 2022. Contact: [email protected]. Help Desk: +32 2 507 20 81 (available 24/7)

Recall details

Recall number: Z-0747-2022
Status: Open, Classified
Initiated by the company: Feb 15, 2022
Recalling firm: Ion Beam Applications S.A.
Quantity: 15 units US; 22 units OUS
Product code: LHN
FDA submissions: K163500
Distribution: IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,

Product description

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235

Code information (models, lots, serial numbers)

PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

IBA Proton Therapy System – Proteus 235 Proteus PLUS/Proteus ONE
Ion Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical
8 recalls1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page