GE HealthCare has begun a recall of several models of its nuclear medicine imaging systems that were found to be at risk of collapsing while in use, potentially crushing or trapping a patient underneath.
The devicemaker began the recall in mid-December, a few weeks before it spun out of the General Electric nest to become a standalone healthcare-focused company. Wednesday, the FDA gave the safety event a Class I rating—the agency’s most severe, indicating an increased risk of serious injury or death.
The recall concerns a total of 1,812 scanners distributed around the world since April 2018, according to entries in the FDA’s recall database; about a third of them are in use in the U.S. The affected devices comprise a long list of models within the 600 and 800 series of GE HealthCare’s nuclear medicine imaging systems.
Like other such systems, the NM 600 and 800 series machines scan the body for radiation left by radioactive tracers given to a patient, then send those readings to a computer to generate images that can help doctors detect organ disorders, track the flow of blood and more.
Each of the recalled systems is equipped with a 1,212-pound detector that’s mounted above the patient platform to perform the scans. According to the recall notice, GE HealthCare discovered that a ball screw that’s meant to stop the suspended detector from uncontrolled movement may be at risk of failing. If that happens, a safety key is supposed to stop the detector from falling, but the company found that some devices are missing the safety mechanism.
If the ball screw fails while a machine is in use and there’s no safety key to stop it, the half-ton detector could fall onto a patient, potentially causing severe injuries or death. To date, the issue has sparked eight complaints, but no reports of injury or death, per the FDA.
The agency has concluded that the fall risk stems from issues with process control in the making of the machines.
GE HealthCare sent an urgent medical device correction in December to healthcare providers using affected models of the nuclear medicine devices. In it, the company advised them to stop using the scanners immediately.
The devicemaker said it would conduct inspections of each affected machine. If the proper safety mitigations are in place, healthcare providers will receive a “release letter” and a machine label certifying that the scanners can be returned to regular clinical use. If not, GE HealthCare pledged to correct the detected issues at no cost to its customers.
To date, the company has inspected almost all installed scanners included in the recall. It has so far found eight missing the safety key, all of which were repaired and returned to clinical use.
"Patient safety is our top priority. 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," a GE HealthCare spokesperson said in a statement sent to Fierce Medtech.
Editor's note: This story has been updated to include a statement from GE HealthCare and additional information about the company's recall efforts.