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

FDA Device Recall #Z-2773-2020 — Class II — April 21, 2020

Recall Summary

Recall Number Z-2773-2020
Classification Class II — Moderate risk
Date Initiated April 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ion Beam Applications S.A.
Location Louvain-la-neuve, N/A
Product Type Devices
Quantity 4 units

Product Description

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.

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.

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Ion Beam Applications S.A.

Recall # Classification Product Date
Z-1497-2026 Class II IBA Proton Therapy System - PROTEUS 235 Feb 3, 2026
Z-2693-2024 Class II IBA Proton Therapy System - PROTEUS 235- Design... Jul 10, 2024
Z-3089-2024 Class II IBA Proton Therapy System - PROTEUS 235 Proteus... Jul 8, 2024
Z-1945-2024 Class II IBA Proton Therapy System - PROTEUS 235 - Desig... May 10, 2024
Z-1603-2024 Class II IBA Proton Therapy System - PROTEUS 235, PTS-10... Mar 4, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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