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 FRx AED Recalled by Philips North America LLC Due to Affected devices contain a Printed Circuit Assembly (PCA)...

Date: September 10, 2019
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 FRx AED, Model 861304, FRx codeRev: E.02.017

Quantity: 44 units

Why Was This Recalled?

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

Where Was This Sold?

This product was distributed to 13 states: CA, CT, FL, IL, MI, MS, MO, NJ, NY, TN, TX, WA, WI

Affected (13 states)Not affected

About Philips North America LLC

Philips North America LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

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