The FDA labeled the recall of the GE HealthCare (Nasdaq:GEHC) Nuclear Medicine 600/800 Series systems as Class I, the most serious kind.
GE HealthCare recalled the imaging platforms after identifying an issue with two mechanisms. These mechanisms prevent uncontrolled detector movement. The issues could result in the suspended mass of the detector potentially falling. A similar issue arose nearly 10 years ago after part of a GE HealthCare Infinia Hawkeye 4 system collapsed and killed a patient.
Should the 1212-pound (550-kg) detector fall, it may crush or trap the patient. GE HealthCare received eight complaints related to the issue, with no injury or death reported.
Details of the GE HealthCare recall
The recall includes a series of models of the Nuclear Medicine 600/800 Series systems. It includes the Brivo 615, Discovery NM 630 and the Optima 640. It also covers the Discovery NM/CT 670 DR, 670 ES, 670 Pro and 670 CZT. The recall includes the NM 830 and 830 ES as well as the NM/CT 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR and 870 ES.
GE Healthcare distributed the affected systems between April 1, 2018 and Dec. 16, 2022. It initiated the recall on Dec. 18, 2022, and recalled 688 devices in the U.S. to date.
The company’s Nuclear Medicine systems evaluate diseases, trauma, abnormalities and disorders. They create images of the body to help healthcare providers assess organ function or detect and diagnose diseases, disorders and cancer.
GE HealthCare said the first risk comes with the ball screw that mitigates the suspended mass of the detector. Some devices also lack a safety key that should prevent the detector from a “catastrophic fall” when the ball screw fails, FDA said.
The company sent customers an urgent medical device correction letter to inform them of the issue. GE HealthCare’s letter recommended that customers stop use of the affected systems until company service technicians complete an inspection.