Proton Therapy Systems May Fail to Verify Beam Range After Pause

Plain-English summary

The ProteusPLUS and ProteusONE proton therapy systems (Proteus 235) are designed to deliver radiation treatment for localized tumors. The recall concerns a software verification issue: when treatment resumes after a pause, the system does not verify whether the beam range has been manually modified during the pause. If an operator changed the range during the pause, the system will resume with an incorrect beam range, potentially delivering radiation treatment with an error in the therapeutic beam range.

Affected units include 15 systems distributed across the United States (Illinois, Kansas, Louisiana, Florida, Michigan, Oklahoma, Pennsylvania, New Jersey, Tennessee, Texas, Virginia, and Washington) and 22 systems distributed internationally (Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands, and others).

Patients and healthcare providers using affected ProteusPLUS or ProteusONE systems should contact the manufacturer, Ion Beam Applications S.A., or the FDA for guidance on verification procedures and corrective actions. Healthcare facilities should review their protocols for confirming beam range settings before resuming treatment.

The recalled product

Product

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

Manufacturer

Ion Beam Applications S.A.

Category

Medical Device — Proton Therapy System

Hazard

• radiation-dosage-error

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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