HQ Team
February 16, 2023: GE Healthcare has pulled out 688 medical systems that evaluate diseases, trauma, abnormalities and disorders, a move which USFDA termed a most severe type of recall.
The Class I recall of GE Nuclear Medicine 600 and 800 systems follow the identification of two medical mechanisms that prevent uncontrolled detector movement, according to a statement from the FDA.
There is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail.
Some devices also miss a safety key that should prevent the detector from catastrophic falls when the ball screw fails.
1,212-pound detector
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, resulting in severe injury or death.
There have been eight complaints, and no injuries and deaths have been reported related to this issue, according to the statement.
The safety key is not visible to or accessible by the patient or the technician who operates it. Only a service technician can inspect it and correct.
People who need nuclear medicine imaging using one of the 600 or 800 Series systems may be affected.
Nuclear medicine imaging
Healthcare personnel (including imaging technicians) who perform nuclear medicine imaging using the 600 or 800 Series systems may also take the brunt.
Hospitals and other healthcare settings that use GE Nuclear Medicine 600 or 800 Series systems for imaging are probably affected.
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.
GE Healthcare started distributing the systems in April 2018 and has recalled 688 machines since December 18, 2022.
The company has sent customers an Urgent Medical Device Correction letter to inform them of the issue. It assured of steps to correct problems with safety mitigation devices.
