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Philips Healthcare Inc. recalls Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termi

Recalled July 18, 2012 · FDA recall Z-1986-2012 · Philips Healthcare

Hazard
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG · FDA Class II
Units
35 units
Sold at
Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA

Description

Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG

Product
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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
Manufacturer(s)
Philips Healthcare Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Philips Healthcare Inc. recalls Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termi | RecallWatchUSA