Update to Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems

Editor's Note

The Food and Drug Administration (FDA) on February 22 updated the Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems.

The recall was initiated by GE HealthCare after identifying an issue with two mechanisms that prevent uncontrolled detector movement—a risk that the ball screw, which serves as design mitigation for the suspended mass of the detector, may fail, and some devices were also missing a safety key that should prevent the detector from a catastrophic fall when the ball screw fails.

If the ball screw fails and the safety key is missing, the 1,212 pound detector could fall and potentially crush or trap a patient.

The issue was identified internally by GE HealthCare, and, while conducting the recall, GE HealthCare identified and corrected 8 instances of the missing safety key.

There have been no complaints, no injuries, and no deaths reported related to the issue.

Distribution dates were April 1, 2018, to December 16, 2022.