FDA classifies recall of certain GE HealthCare Nuclear Medicine Systems as most serious
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The U.S. Food and Drug Administration (FDA) said on Wednesday that it has classified the recall of certain Nuclear Medicine 600/800 Series Systems from GE HealthCare Technologies (NASDAQ:GEHC) as the most serious type, class 1, because their use may cause serious injuries or death.
The devices are being recalled because of risk of detector fall that may injure patients, according to the agency.
These systems are used to create images of the body to help health care providers assess organ function or detect and diagnose certain diseases.
The FDA said GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detector movement.
First, there is a risk that the ball screw which works as design mitigation for the suspended mass of the detector may fail. In addition, some devices are also missing a safety key which 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 could lead to serious injury or death, the agency added.
The FDA noted that there have been eight complaints, no injuries, and no deaths reported related to this issue.
As per the FDA, on Dec. 18, 2022, GE HealthCare sent customers an Urgent Medical Device Correction letter to inform them of the issue.
GE HealthCare recommended customers to stop use of these Nuclear Medicine systems until an inspection is completed by the company's technicians.
In the U.S. 688 devices have been recalled, which had been distributed between April 1, 2018 and Dec. 16, 2022, the FDA noted.
The recall affects the Nuclear Medicine 600/800 Series systems â Product Models: Brivo 615; Discovery NM 630; Optima 640; Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT; NM: 830, 830ES; and NM/CT: 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR, 870 ES, as per the FDA.
GE HealthCare Technologies (GEHC) started trading as a separately company on Nasdaq after its spin-off from General Electric (NYSE:GE) in January.