FDA Deems GE Nuclear Medicine Recall Class I

The FDA has deemed GE HealthCare’s recall of its Nuclear Medicine 600 and 800 Series systems as Class I, the most serious type of recall, as use of the devices may cause serious injury or death.

GE initiated the recall on Dec. 18, 2022, after identifying an issue with two mechanisms that prevent the imaging system’s detector from falling. There is a risk that a ball screw that supports the suspended detector may fail and some devices may lack a safety key to prevent the detector from a catastrophic fall if the ball screw fails.

If the ball screw fails and the safety key is missing, the 1212-pound detector “could fall, potentially crushing or trapping a patient, which may result in serious injury or death,” the FDA said.

The 688 affected devices were distributed tween April 1, 2018, and Dec. 16, 2022. There have been eight complaints, but no reported injuries or deaths linked to the recalled equipment.