Class I Recall of Phillips Healthcare's HeartStart MRx Monitor Defibrillator

PUBLISHED: Mar 24, 2017
Source: Food and Drug Administration

Phillips Healthcare is recalling the HeartSart MRx Mnitor/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.

Recalled Product:

  • HeartStart MRx Monitor/Defibrillator
  • Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Manufacturing dates: February 11, 2004 to November 4, 2016
  • Distribution dates: February 12, 2004 to November 4, 2016
  • Devices Recalled in the U.S.: 47,362 units nationwide

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, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.

On February, 2017, Phillips Healthcare sent an “Urgent Medical Device Correction” notice to its customers. The cause of the issue can be easily verified by:

  • Identifying affected devices in their possession using the model number information;
  • Inspecting that the battery connector pins are clean, fully extended, and free of residue;
  • Following the rest of the instructions enclosed in the notice, including:
  • Reviewing the information with other staff trained in the use of the defibrillator;
  • Filling out and return the ‘Confirmation Response’ included with the notice; and
  • Contacting Phillips Healthcare for further information or support at 1-800-722-9377.

See the Recall Notice for additional information.

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