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FDA Clears GE, Toshiba in Investigation, Recommends Improvements to CTs

November 15, 2010
GE Healthcare and Toshiba America Medical Systems are not to blame for hundreds of incidents of excessive radiation, the FDA says. The agency’s investigation into overdoses during CT scans found no violations of FDA regulations at GE or Toshiba, which had made the equipment used in the hospital scans. However, the investigation revealed improvements industry could make to its equipment, user information and training to improve device safety and reduce the likelihood of overexposures in CT brain-perfusion studies, the FDA says in a letter to the Medical Imaging Technology Association.
Devices & Diagnostics Letter