The Recall Desk
SevereFDA (Devices)·Z-1612-2016·Announced 2016-05-11

Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure

Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. The device is a critical life-support medical device, and a failure to charge poses a significant risk of harm to patients requiring defibrillation, fitting the 'Severe' criteria for significant injury risk or structural defect in a high-risk product.

Plain-English summary

Philips Electronics North America Corporation is recalling 17 units of the HeartStart MRx Monitor/Defibrillator. The recall is due to a defect in the therapy printed circuit board, which may have been loaded with an incorrect electronic component. This defect could cause the device to fail to charge.

The affected devices were distributed worldwide, including in the United States (Ohio, California, and North Carolina) and internationally to China, Iraq, Japan, and Korea. The HeartStart MRx is intended for use by qualified medical personnel trained in basic life support, advanced cardiac support, or defibrillation to terminate ventricular tachycardia and ventricular fibrillation.

Users should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life sup
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • US00586611
  • US00589878
  • US00594232
  • US00588464
  • US00591080
  • US00594779
  • US00588657
  • US00592182
  • US00594913
  • US00589391
  • US00593861
  • US00595298
  • US00589472
  • US00594092
  • US00595443
  • US00589851
  • US00594168

Distribution

Distributed in 3 states:

Same manufacturer · Philips Electronics North America Corporation

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