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 Monitor/Defibrillators Model numbers M3535A Recalled by Philips North America, LLC Due to HeartStart XL MonitorlDefibrillators may not have been included...

Date: April 27, 2020
Company: Philips North America, LLC
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 North America, LLC directly.

Affected Products

Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Quantity: 260 units

Why Was This Recalled?

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America, LLC

Philips North America, LLC has 88 total recalls tracked by RecallDetector.

Related Recalls

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