HUNTSVILLE, Ala. (CN) - A General Electric CAT scanner delivered eight times the expected level of radiation, causing a woman's hair to fall out and putting her at increased risk of brain cancer, she says in a federal class action.
Becky Coudert says the FDA issued a notice last year that more than 200 patients "had received radiation doses that were approximately eight times the expected level ... a much higher level of radiation than was either intended or is reasonably safe."
CAT or CT scanners, or computer-assisted tomography, take X-rays from multiple angles to provide greater detail of the brain.
Coudert says that after she had a CT scan to see if she had suffered a stroke, her hair started falling out.
On Oct. 9, 2008, the U.S. FDA issued a notice that since February of that year more than 200 patients "had received radiation doses that were approximately eight times the expected level. Instead of receiving the expected dose of 0.5 Gy [gamma irradiation] (maximum) to the head, these patients received 3-4 Gy. The FDA further indicated that 'the magnitude of these overdoses and their impact on affected patients were significant,'" according to the complaint. (Parentheses, but not brackets, in original.)
"The FDA further indicated that it had commenced a safety investigation, suggesting that the situation may reflect more widespread problems with CT quality assurance programs. A nationwide alert was issued by the FDA warning hospitals to check CT brain scan procedures.
"Due to either the lack of appropriate safety functions, confusing methodology, or some other cause, the machines in question have emitted a much higher level of radiation than was either intended or is reasonably safe.
"The radiation exposure which results is a proven hazardous substance inasmuch as same is a known carcinogen."
Coudert says she has been told she will need continued monitoring to check for brain cancer.
She demands damages from GE Healthcare for product liability, negligence and breach of warranty, and creation of a fund to pay for medical monitoring.
She is represented by Herman Watson Jr.
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