IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

Plain-English summary

The IBA Proton Therapy System - PROTEUS 235 is designed to produce and deliver a proton beam for treating patients with localized tumors and radiation-susceptible conditions. The FDA has issued a Class II recall affecting 19 units distributed across US states (Illinois, Louisiana, New Jersey, Michigan, Oklahoma, Tennessee, Texas, Virginia, Washington) and international locations (Czech Republic, France, Germany, Italy, Japan, Poland, Russia, Sweden).

The Forte Robotic Patient Positioning System component of this equipment occasionally experiences temporary deactivation of its collision detection feature. Collision detection is critical for preventing the robotic positioning system from striking patients or equipment during treatment setup and beam delivery.

Healthcare facilities should verify whether their systems are affected by checking the device serial numbers against the FDA recall notice. Facilities using recalled units should contact Ion Beam Applications S.A. for remediation guidance. Patients undergoing proton therapy treatment should consult with their treatment team regarding any potential impact on their scheduled care.

The recalled product

Product

IBA Proton Therapy System - 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

Manufacturer

Ion Beam Applications S.A.

Category

Medical Device — Radiation Therapy Equipment

Hazard

• collision-detection-failure
• robotic-system-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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