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 1,212-lb (550-kg) detector fall, it may crush or trap the patient.
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.
According to GE HealthCare, the company moved to minimize disruptions to patient care. Of the approximately 1,850 impacted systems, it inspected nearly all installed. Eight were missing a safety key and all systems were corrected and returned back to clinical use. All systems inspected by GE HealthCare field engineers as a result of this potential issue returned to use.
The company aims to complete the remaining inspections as soon as possible.
“Patient safety is our top priority,” a GE HealthCare spokesperson said in an emailed statement. “We have completed nearly all inspections of potentially impacted devices to ensure the safety key mitigation was appropriately implemented and cleared those systems for clinical use. There are no reports of patient injury or detector collapse as a result of this issue.”
This story was updated with a statement provided by a company spokesperson.