The FDA has stated it is a Class 1, the most serious type. To repair the devices the company will be sending service personnel out to fix the units. These are not consumer units but rather ones used in hospitals or by paramedics.
A unit of Medtronic said Thursday that federal regulators have determined a type of external defibrillator subject to a recent recall could cause serious injury or death.
Medtronic, the world's largest medical device company, told doctors and patients last month about a problem with its Lifepack 15 heart defibrillators that can cause a loss of power. The problem only affects devices made before Dec. 16.