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 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 .
The second letter, sent on July 3, informed centers of the -- not just the one implicated in the patient death -- "because of the similarities in the design of support mechanisms across many products."
The affected systems include Infinia (11 models), VG and VG Hawkeye (six models), Helix (made by Elscint) , Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670, all of which were distributed from October 1992 to June 2013, when the recall was initiated.
"Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost," according to the FDA. "A GE Healthcare representative will contact the hospitals to arrange for the inspection."
A spokesperson for the company said in an email that the global inspections are “nearly complete,†and that “those systems that require repair will be returned to service shortly.â€
The FDA said that adverse reactions or quality problems with the systems can be reported to the agency's adverse event reporting program.
UPDATE: This article, originally published July 30, 2013, at 1:30 p.m. was updated with new material (July 30, 2013, at 4:20 p.m.).