HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues
Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
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