CT Brain Perfusion Scans Safety Investigation: Initial Notification
MedSun: Newsletter #44, January 2010

FDA MedWatch Safety Alert

The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer. On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

Additional Information:

FDA MedWatch Safety Alert. CT Brain Perfusion Scans Safety Investigation: Initial Notification. December 7, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun