GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients

The FDA has identified this as a Class I recall, the most serious type of recall

February 23, 2023 — Editor's note: This news item has been updated to reflect that the FDA has since updated its alert to state that there have been no complaints reported related to the issue, that the issue was identified internally by GE HealthCare, and, while conducting the recall, GE Healthcare identified and corrected eight instances of the missing safety key.

February 15, 2023 — According to the U.S. Food and Drug Administration (FDA), GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms—the ball screw and safety key—that prevent uncontrolled detector movement. 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.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Recalled Product

Product Name: Nuclear Medicine 600/800 Series systems

Product Models:

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

See Medical Device Recall Database entry for more information.

Distribution Dates: April 1, 2018 to December 16, 2022
Devices Recalled in the U.S.: 688
Date Initiated by Firm: December 18, 2022

Device Use

GE Nuclear Medicine 600 and 800 Series systems are used by health care professionals to evaluate diseases, trauma, abnormalities, and disorders. These systems create images of the body to help health care providers assess organ function or detect and diagnose issues such as cardiovascular disease, neurological disorders, and cancer.

Reason for Recall

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 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.

There have been no complaints, no injuries, and no deaths reported related to this issue. This issue was identified internally by GE HealthCare. While conducting this recall, GE HealthCare has identified and corrected eight instances of the missing safety key. (Updated 2/23/23)

Who May be Affected

People who need nuclear medicine imaging using one of the 600 or 800 Series systems.
Healthcare personnel (including imaging technicians) who perform nuclear medicine imaging using the 600 or 800 Series systems.
Hospitals and other healthcare settings that use GE Nuclear Medicine 600 or 800 Series systems for imaging.

What to Do

On December 18, 2022, GE HealthCare sent customers an Urgent Medical Device Correction letter to inform them of the issue. The letter included the following recommendations.

The company recommended customers stop use of these Nuclear Medicine systems until an inspection is completed by GE HealthCare service technicians. They also requested that customers complete the letter’s Acknowledgement Response form and send to [email protected].

As of January 13th, GE has reported that:

Customers will be contacted by a GE HealthCare representative to arrange for the inspection and any needed corrections. During that inspection, a GE HealthCare engineer will:

Ensure all safety mitigations to prevent a catastrophic fall of the detector are in place.
Correct any problems with the 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 about the completed 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. Only a service technician can inspect it and provide a correction.