GE Healthcare Nuclear Medicine Systems: Class I Recall
MedSun: Newsletter #87, August 2013

FDA MedWatch Safety Alert

GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost.

Additional Information:

GE Healthcare Nuclear Medicine Systems: Class I Recall. FDA MedWatch Safety Alert. July 29, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362963.htm


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