The Food and Drug Administration (FDA) on February 15 identified the recall by GE HealthCare of its Nuclear Medicine 600/800 Series systems as Class I, the most serious.
The recall was initiated because of an issue with two mechanisms that prevent uncontrolled detector movement. If the mechanisms fail, the 1,212 pound detector could fall and potentially crush or trap a patient.
There have been eight complaints, no injuries, and no deaths reported.
Distribution dates were April 1, 2018 to December 16, 2022.Read More >>