Sam Brusco, Associate Editor02.16.23
Editor's note: The FDA alert has since been updated to accurately reflect the fact that there have been no complaints reported related to the issue, that 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. View the updated alert here.
The U.S. Food and Drug Administration (FDA) has identified GE HealthCare’s December 18 recall of its Nuclear Medicine 600/800 Series systems as Class I.
The systems are used to evaluate diseases, trauma, abnormalities, and disorders. They create images of the body to help assess organ function or detect and diagnose issues like cardiovascular disease, neurological disorders, and cancer.
GE HealthCare recalled the Nuclear Medicine 600/800 Series systems after identifying a problem with two mechanisms that prevent uncontrolled detector movement. There’s a risk the ball screw that serves as a design mitigation for the suspended mass of the detector may fail. Further, some devices are also missing a safety key that should prevent the detector from a catastrophic fall should the ball screw fail.
If the ball screw fails and the safety key is missing, the 1212-pound detector could fall and potentially crush or trap an object or trap a patient.
688 devices were recalled in U.S., which were distributed between April 1, 2018 and December 16, 2022. Thus far there have been eight complaints (all of which have been identified and corrected by GE HealthCare), no injuries, and no deaths reported related to the problem.
The company recommended customers stop use of these Nuclear Medicine systems until an inspection is completed by GE HealthCare service technicians.
The U.S. Food and Drug Administration (FDA) has identified GE HealthCare’s December 18 recall of its Nuclear Medicine 600/800 Series systems as Class I.
The systems are used to evaluate diseases, trauma, abnormalities, and disorders. They create images of the body to help assess organ function or detect and diagnose issues like cardiovascular disease, neurological disorders, and cancer.
GE HealthCare recalled the Nuclear Medicine 600/800 Series systems after identifying a problem with two mechanisms that prevent uncontrolled detector movement. There’s a risk the ball screw that serves as a design mitigation for the suspended mass of the detector may fail. Further, some devices are also missing a safety key that should prevent the detector from a catastrophic fall should the ball screw fail.
If the ball screw fails and the safety key is missing, the 1212-pound detector could fall and potentially crush or trap an object or trap a patient.
688 devices were recalled in U.S., which were distributed between April 1, 2018 and December 16, 2022. Thus far there have been eight complaints (all of which have been identified and corrected by GE HealthCare), no injuries, and no deaths reported related to the problem.
The company recommended customers stop use of these Nuclear Medicine systems until an inspection is completed by GE HealthCare service technicians.