Philips Medical Systems, Inc. recalls Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MR…

Recall date

November 19, 2014

Source

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

Recall number

Z-0262-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,…

Why it was recalled

MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.

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

What was recalled

Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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