The U.S. Food and Drug Administration (FDA) has announced a Class 1 recall of the GE Healthcare Nuclear Medicine Imaging Systems. The recall was announced following an incident in which a part of the machine collapsed and killed a patient who was being scanned. The FDA and GE have ordered hospitals to stop using the recalled nuclear medicine systems until they are inspected for safety.
What You Can Do & How a GE Nuclear Medicine System Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting GE Healthcare Nuclear Medicine Imaging System induced injury cases in all 50 states. If you or somebody you know was injured by a defective nuclear medicine system, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is the GE Nuclear Medicine Imaging System?
GE Healthcare manufactures several types of Nuclear Medicine Imaging Systems. These medical devices are used to produce 3D images of a patient’s internal anatomy.
The procedure begins when a patient is given an intravenous injection of a radioactive material. A few hours later, the patient rests on a special bed on the machine. The bed moves the patient’s head into a doughnut-shaped hole surrounded by gamma cameras behind panels. The panels are made of thick layers of lead that can weigh hundreds of pounds. The cameras and scanners rotate around the patient’s body and detect radiation emitted by the radioactive material in the patient’s body.
The images are processed by computer software that builds an image of the patient’s deep tissues and internal organs, similar to an MRI or CAT scan. Nuclear medicine systems are used to pinpoint diseases (such as cancer) in a minimally-invasive procedure.
What is the problem?
On June 5, 2013, a man died when loose bolts allowed a camera to fall off a GE Healthcare Infinia Hawkeye 4 nuclear medicine system. The 66 year-old man was undergoing a procedure at the J. Peters Veterans Medical Center in New York.
The Infinia Hawkeye 4 is one of the largest nuclear medicine systems on the market and can weigh up to 5,000 pounds. The hospital said that the camera was installed in 2006 and maintained by the manufacturer.
According to GE Healthcare:
“Bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. The safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam.”
FDA Safety Warning for Nuclear Medicine Systems
The FDA announced a recall of the GE Healthcare Nuclear Medicine System on July 29, 2013. They issued a Class 1 recall, which is the most serious type of recall, because “serious injuries or deaths could occur.”
The FDA action follows several actions from GE Healthcare. The company learned about the incident on June 5 and inspected the machine June 17. On July 3, GE issued an Urgent Medical Device Recall.
Nuclear Medicine System Recall
GE has recalled the Infinia Hawkeye 4, the nuclear medicine system implicated in the death of one man, as well as several other nuclear medicine systems with a similar design. The machines were sold from October 1992 – June 2013. GE is inspecting and repairing the machines at no cost. Healthcare facilities are instructed to stop using the systems until they are inspected by a GE representative.
GE nuclear medicine system recalls include:
- Infinia Nuclear Medicine Systems
- VG and VG Hawkeye Nuclear Medicine Systems
- Helix Nuclear Medicine Systems
- Brivo NM615
- Discovery NM630
- Optima NM/CT640
- Discovery NM/CT670
- And more
Do I have a GE Nuclear Medicine System Lawsuit?
The Schmidt Firm, PLLC is currently accepting GE Healthcare Nuclear Medicine Imaging System induced injury cases in all 50 states. If you or somebody you know was injured by a defective nuclear medicine system, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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