Philips Medical Systems, Inc. recalls HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6…

Recall date

December 23, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0219-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name:…

Why it was recalled

MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: 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