Ion Beam Applications S.A.: Proteus 235 Proton Therapy System Recalled for Collision Detection Failure

Agency Publication Date: August 21, 2024

Summary

Ion Beam Applications is recalling 19 units of the IBA Proton Therapy System - PROTEUS 235 because the robotic patient positioning system may experience issues with its collision detection system being temporarily deactivated. This system is designed to deliver proton beams to treat localized tumors, and a failure in collision detection could lead to unexpected contact between the robotic equipment and other objects or persons. Affected units were distributed across nine U.S. states and eight foreign countries. Consumers should contact their healthcare provider or the manufacturer for specific instructions regarding this device.

Risk

The temporary deactivation of the collision detection system allows the robotic positioning equipment to potentially collide with surrounding structures or staff, which could cause mechanical damage or physical injury during radiation treatment sessions.

What You Should Do

Identify if your facility is using an IBA Proton Therapy System - PROTEUS 235 by checking the serial number on the unit or in your maintenance records.
Verify if your device matches one of the affected U.S. serial numbers: PAT.108, PAT.110, PAT.112, PAT.113, SAT.116, SAT.119, SAT.123, SAT.126, or SBF.105.
If you are located in the Czech Republic, France, Germany, Italy, Japan, Poland, Russia, or Sweden, check for serial numbers: PAT.111, PAT.114, PAT.115, SAT.117, SAT.118, SAT.120, SAT.122, SBF.101, SBF.103, or SBF.104.
Check for the Universal Device Identifier (UDI-DI) (01)05404013801138 located on the product labeling.
Contact Ion Beam Applications S.A. immediately to discuss the temporary deactivation issues and to schedule any necessary software updates or technical inspections.
Contact your healthcare provider or the manufacturer for further instructions and potential remedy options.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer initiated notification and technical review

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: IBA Proton Therapy System - PROTEUS 235

Lot Numbers:

PAT.108

PAT.110

PAT.111

PAT.112

PAT.113

PAT.114

PAT.115

SAT.116

SAT.117

SAT.118

SAT.119

SAT.120

SAT.122

SAT.123

SAT.126

SBF.101

SBF.103

SBF.104

SBF.105

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95024

Status: Active

Manufacturer: Ion Beam Applications S.A.

Sold By: Ion Beam Applications S.A.

Manufactured In: Belgium

Units Affected: 19 units

Distributed To: Illinois, Louisiana, New Jersey, Michigan, Oklahoma, Tennessee, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility is using an IBA Proton Therapy System - PROTEUS 235 by checking the serial number on the unit or in your maintenance records.

Verify if your device matches one of the affected U.S. serial numbers: PAT.108, PAT.110, PAT.112, PAT.113, SAT.116, SAT.119, SAT.123, SAT.126, or SBF.105.

If you are located in the Czech Republic, France, Germany, Italy, Japan, Poland, Russia, or Sweden, check for serial numbers: PAT.111, PAT.114, PAT.115, SAT.117, SAT.118, SAT.120, SAT.122, SBF.101, SBF.103, or SBF.104.

Check for the Universal Device Identifier (UDI-DI) (01)05404013801138 located on the product labeling.

Contact Ion Beam Applications S.A. immediately to discuss the temporary deactivation issues and to schedule any necessary software updates or technical inspections.

Contact your healthcare provider or the manufacturer for further instructions and potential remedy options.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.