FDA: Class I recall of HeartStart MRx Monitoy/Defibrillator

Editor's Note

The Food and Drug Administration (FDA) on March 24 identified the recall of the HeartStart MRx Monitor/Defibrillator by Phillips Healthcare (Amsterdam) as Class I, the most serious.

The recall was initiated because of electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock. The device also may unexpectedly stop pacing. A delay in delivering therapy could result in permanent organ damage, brain injury, or death.

Device manufacturing dates are February 11, 2004 to November 4, 2016, and distribution dates are February 12, 2004 to November 4, 2016.