GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms—the ball screw and safety key–that prevent uncontrolled detector movement. If the ball screw fails and the safety key is missing, the 1212-pound (550-kg) detector could fall, potentially crushing or trapping a patient.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
