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.

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.

Who May be Affected

• People who need nuclear medicine imaging using one of the 600 or 800 Series systems.
• Health care personnel (including imaging technicians) who perform nuclear medicine imaging using the 600 or 800 Series systems.
• Hospitals and other health care 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.
• Provide updated service instructions, and apply a service label on an interior component to ensure future service activities follow the latest service instructions.

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.

Contact Information

Customers with questions about this recall should contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Additional Resources:

• Class 1 Device Recall GE
• Class 1 Device Recall GE
• Class 1 Device Recall GE
• Class 1 Device Recall GE
• Class 1 Device Recall GE
• Class 1 Device Recall GE

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.