Ion Beam Applications S.A.: Proton Therapy System Recalled for Potential Patient Crushing Risk

Agency Publication Date: November 14, 2023

Summary

Ion Beam Applications S.A. has recalled 14 units of the IBA Proton Therapy System (PROTEUS 235) because the patient positioning system can move in unexpected directions. This defect creates a dangerous situation where a patient could be crushed between the positioning devices. The recall affects specific PROTEUS 235 systems configured with the Orion Patient Positioning System version OSS6.0, which were distributed to cancer treatment centers across several states and countries.

Risk

The software or mechanical control of the patient positioning system may cause the table to move unexpectedly, potentially trapping and crushing a patient against other components of the proton therapy equipment.

What You Should Do

Identify if your facility is using the affected IBA Proton Therapy System (PROTEUS 235) with Orion Patient Positioning System (version OSS6.0). Check your system's serial number for the following affected units in the US: SAT133, SAT140, SBF113, SBF128, or SBF135.
For international facilities, verify if your system matches these serial numbers: SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, or SBF125.
If you are a patient receiving treatment at a facility using this equipment, discuss any safety concerns with your oncology team or healthcare provider.
Medical facilities and healthcare providers should contact Ion Beam Applications S.A. at Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, Belgium, for technical instructions and potential system updates or repairs.
For more information regarding this recall, contact the FDA's medical device division at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Technical Instruction

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

Affected Products

Product: IBA Proton Therapy System - PROTEUS 235 (Orion PPS version OSS6.0)

Model / REF:

PTS-11

PTS-12

Lot Numbers:

SAT133

SAT140

SBF113

SBF128

SBF135

SAT125

SAT127

SAT132

SAT136

SBF107

SBF112

SBF117

SBF124

SBF125

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93293

Status: Active

Manufacturer: Ion Beam Applications S.A.

Sold By: Ion Beam Applications S.A. direct sales

Manufactured In: Belgium

Units Affected: 5 (US), 9 (OUS)

Distributed To: Arkansas, Florida, Kansas, Virginia

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 the affected IBA Proton Therapy System (PROTEUS 235) with Orion Patient Positioning System (version OSS6.0). Check your system's serial number for the following affected units in the US: SAT133, SAT140, SBF113, SBF128, or SBF135.

For international facilities, verify if your system matches these serial numbers: SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, or SBF125.

If you are a patient receiving treatment at a facility using this equipment, discuss any safety concerns with your oncology team or healthcare provider.

Medical facilities and healthcare providers should contact Ion Beam Applications S.A. at Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, Belgium, for technical instructions and potential system updates or repairs.

For more information regarding this recall, contact the FDA's medical device division at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.