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 support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Reported: May 11, 2016 Initiated: April 14, 2016 #Z-1612-2016
Product Description
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 support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Reason for Recall
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 17
- Distribution
- Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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 support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.. Recalled by Philips Electronics North America Corporation. Units affected: 17.
Why was this product recalled? ▼
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2016. Severity: Moderate. Recall number: Z-1612-2016.
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