FDA Blames GE, Toshiba Radiation Problems On Misuse

Law360, New York (November 9, 2010, 2:58 PM EST) -- The U.S. Food and Drug Administration said Tuesday that CT scan equipment made by General Electric Co. and Toshiba Corp. units did not malfunction if properly used, blaming the radiation overexposure of hundreds of patients on human error.

While the equipment made by GE Healthcare and Toshiba America Medical Systems was not defective, the FDA said that enhancements to CT scan equipment could reduce the chances of radiation overexposure if misuse does occur.

Potential changes include a console notification to alert operators of high radiation doses,...
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