Class I Recall Issued For Samaritan Defibrillators
The U.S. Food and Drug Administration (FDA) issued a Class I recall of some Samaritan defibrillators made by HeartSine due to battery problems that could lead devices to switch on and off during a cardiac event and lead to the injury or death of a patient. A Class I recall is the most serious safety warning issued by the agency. The FDA said that the U.K. manufacturer notified customers that certain Samaritan 300/300P public access defibrillators (PADs) may intermittently turn on