Safety Investigation of CT Brain Perfusion Scans - Update
MedSun: Newsletter #55, December 2010

FDA MedWatch Safety Alert

The reported cases of radiation overdose involved scanners manufactured by GE Healthcare and Toshiba America Medical Systems. FDA inspections of the companies found there were no violations of FDA laws and regulations. The FDA evaluated the manufacturers' specifications for multi-slice CT scanners and found that when these scanners were used according to the manufacturers’ specifications, they did not result in overexposure. Further, the FDA found no evidence that the manufacturers were involved in modifying any of the hospitals’ scanning protocols so as to cause the overexposures. The FDA is working with manufacturers of CT scanners to improve their instructions and training programs for this complex equipment, and to provide software safety checks that would prevent unreasonably high radiation doses from being delivered unintentionally.

Additional Information:

FDA MedWatch Safety Alert. Safety Investigation of CT Brain Perfusion Scans – Update. November 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm


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