Device Recall Philips Medical HeartStart MRx Defibrillator Monitor

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US00204403 US00533229 US00213079 US00212023 US00206830 US00101201 US00317052 US00535411 US00317517 US00206256 and US00100830.

Cardiovascular Devices

3

No

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HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). || 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.