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Malfunctioning Brain Cancer Radiation Equipment

Patients with brain tumors may have been exposed to the wrong dose of radiation because of a malfunctioning radiation system called Novalis, made by BrainLAB, a German manufacturer. Two clinics in the United States have recently discontinued use of the Novalis system due to the malfunction: The Cleveland Clinic in Ohio and The Valley Medical Center in Renton, Washington. These clinics have been using the BrainLAB equipment since 2004. Some 550 BrainLAB radiotherapy machines are used around the world, with the majority in the United States.

Targeting Errors

The malfunction is in the system's targeting mechanism. According to the Associated Press, BrainLAB's June 4 notification to hospitals that use the Novalis system said that the result of the system's malfunction is that a "patient is set to an unintended position" when receiving radiation treatment. The letter added that "This may cause serious injury or death to the patient."

Healthy Tissue Could Be Destroyed

Radiation therapy for a brain tumor typically involves a one-time blast of high-energy radiation that is aimed at a tumor from several sources focused on the tumor to kill it. The margin of error is about 0.8 millimeters. The margin of error given by the malfunctioning BrainLAB equipment is 1.25 millimeters. A radiation therapy expert, Dr. Georges Noel of the Paul Strauss Cancer Center in Strasbourg, France, noted that "A mistargeted machine could irradiate healthy brain tissue. . . . It could kill healthy tissue."

The government of France has ordered that all of the BrainLAB systems in France be shut down. In the United States, the Food and Drug Administration (FDA) regulates radiation therapy, but FDA spokeswoman Julie Zawisza said recently that the agency had no knowledge of the problem with BrainLAB equipment.


Have you undergone radiation that may have used BrainLAB equipment? Contact an experienced medical malpractice attorney today to discuss your case.

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