Royal Philips Electronics N.V.'s HeartStart MRx Recall Is Class I, Says the FDA

The FDA today classified a Royal Philips (NYSE:PHG) recall of its HeartStart MRx monitor/defibrillator 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 HeartStart MRx monitor/defibrillator is designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest or to pace individuals with a slow heart beat, according to the FDA.

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