Last November the Food and Drug Administration issued a recall on some models of external defibrillators, a staple in many facilities nursing home supply. The original recall included defibrillators manufactured by Cardiac Science Corporation and now included GE’ s Responder, and two Nihon Kohden model’s also made by Cardiac Science. This brings the total defibrillator recall count to nearly 300,000.
"The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
In addition to nursing home supply, external defibrillators can be found in airports, hospitals, homes, and other public places and are integral in reviving someone struck with sudden cardiac arrest. According to the FDA, the devices were recalled because they suffer from a malfunction of the relay component and have faulty resistors.
Because of these defects, the recalled devices may not be able to administer the life-saving shocks needed to revive someone in an emergency. In addition, the FDA stated that the defects may not be able to properly recognize electrode placement.
The recall affects defibrillators manufactured between August 2003 and August 2009. Models affected are:
Powerheart-9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
CardioVive- 92531, 92532, 92533
Nihon Kohden-9200G and 9231
GE Responder-2019198, 2023440
