The FDA announced on Monday a class I recall of GE Healthcare's nuclear medicine systems stemming from a patient death reported last month.
On June 5, the company learned that a patient at a VA Medical Center had been crushed and killed when part of an Infinia Hawkeye 4 Nuclear Medicine System fell during a scan. The Wall Street Journal identified the victim as a 66-year-old patient at the James J. Peters VA Medical Center in New York City.
"Bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident," the company determined after inspecting the system.
GE Healthcare sent two letters to hospitals regarding the issue. The first, sent on June 17, "identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling," in addition to asking that the Safety Chapter Sections be re-reviewed with hospital personnel, the FDA said in its recall notice.
