Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips HeartStart FR3 Defibrillator Recalled by Philips Electronics North America Corp. Due to Automated external defibrillators may not fully meet IPx5...
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 Electronics North America Corp. directly.
Affected Products
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.
Quantity: 432
Why Was This Recalled?
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Electronics North America Corp.
Philips Electronics North America Corp. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report