Paris – Hundreds of brain cancer patients in France and perhaps others in the United States may be contacted about their radiation treatments from malfunctioning machines, which were ordered shut down by the French government after a manufacturer’s warning.
The maker of the equipment, Brainlab of Munich, Germany, downplayed the risks, and the company’s founder said it involved a small targeting error that was unlikely to cause problems for patients. However, a company notification sent to a U.S. clinic warned the problem could cause “injury or death.”
Brainlab officials said they believe the malfunction occurred in seven models in use worldwide.
Four hospitals in France, two in the United States and one in Spain have the equipment, but the company would not name the U.S. hospitals. Brainlab would say only that U.S. government health authorities and the affected U.S. hospitals were notified.
A company official said the hospitals were in Ohio and Washington state.
Martin Weinhouse, a physics expert at Cleveland Clinic, said the problem involves a small aiming error that can occur when Brainlab’s Novalis system is used with another manufacturer’s head frame, a device that circles the head and is used in delivering radiation.
Weinhouse said the error involves a deviation of about 1.25 millimeters, similar to variations inherent in the delivery system anyway and he did not believe it would lead to serious problems.
The U.S. Food and Drug Administration, which regulates radiation therapy, had no immediate comment.
Dr. Georges Noel, a radiotherapy expert at the Paul Strauss cancer center in Strasbourg, France, said machine malfunctions were potentially harmful.
“A mistargeted machine could … kill healthy tissue,” Noel said. Whether this would have a large or small effect on the patient depends on the part of the brain affected, he said.
About 550 Brainlab radiotherapy machines are in use worldwide – the largest number of them in the United States.
