GE HealthCare is recalling some of its nuclear medicine imaging systems amid concerns they could cause serious injury or death.
The U.S. Food and Drug Administration alerted patients and providers about the issue Wednesday afternoon, labeling it as the agency’s “most serious” type of recall. It pertains to GE’s Nuclear Medicine 600 and 800 Series systems, used for detecting and diagnosing cancer, neurological disorders and cardiovascular disease, the FDA said.
Two mechanisms in the machines—meant to prevent any uncontrolled detector movement—have posed problems. There’s risk a ball screw on the detector might fail, and some devices may be missing a safety key that prevents the detector from a “catastrophic fall.”
“If the ball screw fails and the safety key is missing, the 1,212-pound (550-kg) detector could drop, potentially crushing or trapping a patient, which may result in serious injury or death,” the alert noted.
To date, there have been eight complaints about this issue but zero instances of injury or death.
GE HealthCare first began alerting customers about concerns with the imaging systems in December. The global medical technology company advised providers to stop using these products until an inspection was completed by one if its technicians. GE reported in January that its representatives had begun reaching out to arrange appointments, during which they corrected the issue and applied labels to devices that are in compliance.
FDA officials warned imaging providers not to assess or attempt to fix the systems themselves.
“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,” the agency noted. “Only a service technician can inspect it and provide a correction.”
GE HealthCare first identified the issue internally and says it has moved swiftly to minimize any disruptions to patient care. Out of nearly 1,900 potentially impacted systems, only eight were discovered to have a missing safety key.
“Patient safety is our top priority,” a GE HealthCare spokesperson said Wednesday. “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 as a result of this issue.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.