Editor’s note: While conducting the following recall, GE HealthCare identified and corrected eight instances of the missing safety key. There have been no complaints reported related to the issue, and the issue was identified internally by GE HealthCare.
GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detector movement, according to a report from the U.S. FDA.
First, there is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail. Additionally, some devices are 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, potentially crushing or trapping a patient, which may result in serious injury or death. The FDA has identified this as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
GE Nuclear Medicine 600 and 800 Series systems are used by healthcare professionals to evaluate diseases, trauma, abnormalities, and disorders. These systems create images of the body to help healthcare providers assess organ function or detect and diagnose issues such as cardiovascular disease, neurological disorders, and cancer.
On Dec. 18, 2022, GE HealthCare sent customers an Urgent Medical Device Correction letter to inform them of the issue. The company recommended customers stop use of these Nuclear Medicine systems until an inspection is completed by GE HealthCare service technicians.