ISSUE: 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.
See the FDA Recall Notice for a list of affected model numbers.
BACKGROUND: The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.
RECOMMENDATION: In February 2017, Phillips Healthcare sent an “Urgent Medical Device Correction” notice to its customers. The cause of the issue can be easily verified by:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the FDA recall notice, at: