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Jun 06, 2023

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

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.

See Medical Device Recall Database entry for more information.

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.

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.

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:

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.

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

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.

02/22/2023