Class II — Potential Health Hazard

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

HeartStart MRx Monitor/Defribillator Recalled by Philips Healthcare Inc. Due to Device may fail to deliver defibrillation therapy in...

Date: April 8, 2013
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

HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Quantity: 64972

Why Was This Recalled?

Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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