FDA: GE Healthcare Recalls Nuclear Medicine Systems Due to Patient Injury Risk

(UPDATED) GE HealthCare says it is recalling 688 of its Nuclear Medicine 600/800 series imaging systems after identifying two separate issues that could cause the massive detectors positioned above patients during scans to fall on them. The US Food and Drug Administration has identified this as a Class I recall, the most serious type.

The first issue involves potential failure of the ball screw that serves as a design mitigation for the suspended mass of the detector. The second issue is related to reports of missing safety keys meant to prevent the suspended detectors from falling if the ball screw fails.

“If the ball screw fails and the safety key is missing, the 1,212-pound (550-kg) detector could fall, potentially crushing or trapping a patient, which may result in serious injury or death,” the FDA says in the recall notice.

No injuries or deaths have been reported, and there have been no complaints related to the two issues. GE HealthCare told TCTMD that the issues were identified internally and that while conducting the recall, they identified and corrected eight instances of the missing safety key. The company says it has notified customers to stop using the machines until it can arrange for inspection and/or corrections. During the inspection, a GE HealthCare engineer will:

• Check that safety mitigations are in place
• Correct problems with safety mitigation devices
• Provide the customer with a “release letter” indicating that the unit can be returned to clinical use
• Apply a label to the device documenting the inspection and provide an updated service addendum

“It is also important to note that the safety key is not visible to or accessible by the patient or the technician who operates it,” the recall notice states. “Only a service technician can inspect it and provide a correction.”

The affected imaging models are:

• Brivo 615
• Discovery NM 630
• Optima 640
• Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT
• NM 830 and 830ES
• NM/CT: 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR, 870 ES

Note: An earlier version of this story incorrectly stated, based on information originally provided by the FDA, that there were eight complaints. GE HealthCare issued a correction, which has been made to our story.