The FDA today labeled a select recall of Physio-Control Lifepak 1000 defibrillators over electrical issues as Class I.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The company’s Lifepak 1000 defibrillator is designed to deliver lifesaving electrical shocks to individuals with sudden cardiac arrest.
