HeartStart MRx Monitor/Defibrillator Recall

HeartStart MRx Monitor/Defibrillator Recall
The HeartStart MRx Monitor/Defibrillator recall was announced in February 2017 for more than 47,000 emergency defibrillators. According to the U.S. Food & Drug Administration (FDA), the devices included in the recall may fail to work properly, resulting in potentially fatal injury to patients.

Attorneys Investigating HeartStart MRx Monitor/Defibrillator Failures

The nationwide law firm of Bernstein Liebhard LLP has launched an investigation into injuries and deaths possibly associated with the HeartStart MRx Monitor/Defibrillator recall. If you or loved one were harmed because this device failed to deliver needed shock therapy, please call (888) 994-5118 to speak with an attorney today.

What Was the HeartStart MRx Monitor/Defibrillator Recall About?

The HeartStart MRx Monitor/Defibrillator is employed in emergency situations to restart the heart in patients experiencing cardiac arrest. It also provides pacing to patients experiencing a slow heartbeat. The device is intended to be used by EMTs and other medical professionals trained in CPR.

On February 24, 2017 Philips Healthcare issued an “Urgent Medical Device Correction” to warn customers of electrical and battery connection issues that could result in “abnormal device behavior.” The problems could prevent the HeartStart MRx Monitor/Defibrillator  from charging properly or delivering a life-saving electrical shock to patients in cardiac arrest. It may also unexpectedly stop pacing a person’s heart during use. Philips warned  that the problems will continue until the unit is reset, and indicated that it was “evaluating both software and hardware changes to prevent this abnormal device behavior.”

On March 24, 2017, the FDA announced that it had placed the HeartStart MRx Monitor/Defibrillator recall in Class I, its most serious recall category. Class I recalls involve products that pose a risk of serious injury or death. According to the FDA, malfunction of a HeartStart MRx Monitor/Defibrillator could result in:

  • Permanent organ damage
  • Brain injury
  • Death

The HeartStart MRx Monitor/Defibrillator recall involved 47,362 units with model numbers:

  • M3535A (M3535ATZ)
  • M3536A (M3536ATZ)
  • M3536M
  • M3536MC
  • M3536M2
  • M3536M4
  • M3536M5
  • M3536M6
  • M3536M7
  • M3536M8
  • M3536M9

Affected devices were manufactured from February 11, 2004 to November 4, 2016, and were distributed from February 12, 2004 to November 4, 2016.

Learn More about Filing a HeartStart MRx Monitor/Defibrillator Lawsuit

You may be entitled to compensation if you or a loved one suffered serious injuries due to the failure of the HeartStart MRx Monitor/Defibrillator. To learn more about your available legal options, please call (888) 994-5118.

Last Modified: May 2, 2017

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