GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems Over Mechanical Issues
The USFDA on Wednesday reported that GE Healthcare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detector movement.
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.
USFDA said that 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 1212-pound (550-kg) detector could fall, potentially crushing or trapping a patient, which may result in serious injury or death," the top US regulator said, adding that there have been eight complaints, no injuries, and no deaths reported related to this issue till now.
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.
Apart from patients, the series systems can also affect healthcare personnel (including imaging technicians) who perform nuclear medicine imaging using the series systems, the FDA said.
