Search Results

GE Healthcare’s Nuclear Imaging System Recalled Due To Patient Safety Risk August 6, 2013 The U.S. Food and Drug Administration (FDA) is initiating a voluntary recall on GE Healthcare’s Infinia Hawkeye 4 Nuclear Imaging System because of a serious risk to patient safety posed by the Defective Medical Device. The unit is comprised of several different cameras and imaging systems that use signals from radioactive isotopes (more...)

FDA Discusses Importance Of Reporting Defective Medical Devices July 16, 2013 Each year, there are numerous cases of people who are injured as the result of using a Defective Medical Device—including children. The U.S. Food and Drug Administration (FDA) recently discussed these dangers, what they are doing to fix the problem, and what consumers should do in the event they discover a fault in (more...)

FDA Announces Recall Of Defective Medical Device April 30, 2013 The U.S. Food and Drug Administration (FDA) announced the voluntary recall of the Zilver® PTX® Drug Eluting Stent manufactured by Cook Medical due to malfunctions that could compromise patient safety. The device is a expanding metal mesh tube that is coated with a medication. The device is used to keep arteries in (more...)

FDA Raises The Status On Defective Insulin Pump Recall April 9, 2013 The U.S. Food and Drug Administration has bumped the voluntary recall on Animas 2020 Insulin infusion pumps to a Class I status. This means use of the Defective Medical Device could result in serious injury or death. According to an article from Medpage Today, the recall affects all pumps that were manufactured (more...)