GE HealthCare recalls imaging devices for patient-crushing risk

USA — GE HealthCare has initiated a Class I recall of the Nuclear Medicine 600/800 Series systems, according to the U.S. Food and Drug Administration (FDA).

The recall is due to an issue with two mechanisms, the ball screw and safety key, which prevent uncontrolled detector movement.

If the ball screw fails and the safety key is missing, the 1212-pound (550-kg) detector could fall, potentially causing serious injuries, health consequences, or death to a patient.

The recall covers a series of models of the Nuclear Medicine 600/800 Series systems, including the Brivo 615, Discovery NM 630, Optima 640, and others.

These systems were distributed between April 1, 2018, and Dec. 16, 2022, with 688 devices recalled in the U.S. to date.

GE HealthCare’s Nuclear Medicine systems are used to evaluate diseases, trauma, abnormalities, and disorders, creating images of the body to assist in assessing organ function or detecting and diagnosing diseases, disorders, and cancer.

The issue with the ball screw that mitigates the suspended mass of the detector could result in the suspended mass of the detector falling.

Additionally, some devices lack a safety key that should prevent the detector from a “catastrophic fall” when the ball screw fails.

GE HealthCare has sent customers an urgent medical device correction letter, recommending that customers stop using the affected systems until company service technicians complete an inspection.

The recall is the most serious type of recall, a Class I recall, according to the FDA. This issue is not the first time a similar problem has arisen with GE HealthCare’s imaging platforms.

Nearly 10 years ago, part of a GE HealthCare Infinia Hawkeye 4 system collapsed, resulting in the death of a patient.

In the meantime, GE HealthCare has acquired Caption Health, Inc., a healthcare leader that uses artificial intelligence (AI) to aid in early disease detection and assist in conducting ultrasound scans.

The acquisition supports GE HealthCare’s US$3B Ultrasound business by adding AI-enabled image guidance to ultrasound device portfolios.

This acquisition aligns with the strategy to deliver precision care, expand access to new ultrasound users, and enable new clinical uses.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.