GE Healthcare has issued a nationwide recall for its Nuclear Medicine Imaging Systems after a patient died due to injuries sustained while being scanned on one of the machines. These devices are used to perform general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in a patient’s body. The U.S. Food & Drug Administration (FDA) has instructed healthcare facilities to discontinue use of GE Nuclear Medicine Imaging Systems until a certified field engineer performs a complete inspection of the devices and performs any necessary repairs.
GE Nuclear Medicine Systems Recall
GE Healthcare has advised the public and medical communities to discontinue use of more than 20 models of its nuclear imaging devices until the company can inspect each one and ensure that it does not have the same problems that led to the death of a patient last month. According to reports, the bolts came loose on a GE Infinia Hawkeye 4 Nuclear Medicine System device, dropping the attached camera and killing the patient. In the weeks that followed, the company warned consumers to avoid being treated with Infinia scanners until GE inspectors could check every device to ensure they were safe. This month, the company has updated the recall to include all of its nuclear medicine systems, saying that design similarities between all of the devices could put patients at risk of serious injuries and even death. Products involved in this recall 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
According to an FDA Safety Alert, this is a Class I recall, which is reserved for devices that can lead to severe injuries and death. It is unclear how many GE Nuclear Medicine Systems around the country are affected by this recall, and the company has not stated how long the inspection process will take.
GE said in a statement that it expanded the recall to ensure “a high level of safety and quality,” recommending that all facilities discontinue use of the devices until it can ensure they are safe to use.
“GE is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible,” according to a statement.
Do I Have a GE Nuclear Medicine Systems Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GE Nuclear Medicine Systems recall lawsuits. We are handling individual litigation nationwide and currently accepting new GE Nuclear Medicine Systems injury and death cases in all 50 states.
If you’ve been injured by a GE Nuclear Medicine System, or if a loved one died while being scanned on one of the devices, you should contact our law firm immediately. You may be entitled to compensation by filing a GE Nuclear Medicine Systems recall suit and we can help.