Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart Recalled by Philips Healthcare Inc. Due to Defibrillator/monitor cannot analyze an ECG report during acquisition...

Date: June 20, 2012
Company: Philips Healthcare Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare Inc. directly.

Affected Products

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

Quantity: 35 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 8 states: FL, IN, MA, NY, OH, TN, TX, VA

Affected (8 states)Not affected

About Philips Healthcare Inc.

Philips Healthcare Inc. has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report