The U.S. Food and Drug Administration (FDA) has partnered with GE Healthcare in initiating a voluntary recall of the company’s Infinia Hawkeye 4 Nuclear Medicine System. The recall was initiated due to malfunctions with the Defective Medical Device that can cause patients to be fatally injured.
The device is used is used to create images based on radioactive isotope tracers ingested by patients. These images can be used by doctors to diagnose certain conditions affecting the brain or heart. It can even be used to recognize certain cancers.
The problem with the device was discovered on July 3 when a camera inside a unit at a VA medical center collapsed on top of a patient. The weight of the camera crushed and killed the victim.
According to an FDA Press Release, facilities in possession of affected units have been instructed to halt use immediately and contact the manufacturer to schedule a repair free of charge. The FDA is also recommending that anyone who suffers an adverse health event associated with the device report the issue to the agency’s MedWatch program.
The Colorado Personal Injury Lawyers with McDivitt Law Firm would also encourage patients who have been injured by the defective medical device discuss their legal rights with a qualified attorney immediately.