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FDA has become aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis and treatment of stroke, the agency said in an initial notification of a safety investigation involving a multi-slice scanner. The notice, issued Thursday, did not name the facility.

However, the agency reported, that this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion).



Following are excerpts from the alert notice:

Over an 18-month period, 206 patients at a particular facility received radiation doses that were approximately eight times the expected level. Instead of receiving the expected dose of 0.5 Gy (maximum) to the head, these patients received 3-4 Gy. In some cases, this excessive dose resulted in hair loss and erythema. The facility has notified all patients who received the overexposure and provided resources for additional information.

If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.

Read the full notice including recommendations for patients, hospitals and imaging centers:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm