Philips HeartStart FR3 Automated External Defibrillator — Class II medical device recall Z-1225-2014
Terminated recall by Philips Medical Systems North America Inc., reported 2014-03-26, distributed in AL, CA, CO, DC, FL, GA, HI, KS…. Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board
| Recall number | Z-1225-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems North America Inc., Bothell, WA, United States |
| Recall initiated | 2014-02-06 |
| Classified | 2014-03-19 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2017-06-29 |
| Distributed | AL, CA, CO, DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA, WI |
| Countries outside the US | AT, AU, CA, CH, DE, FR, GB, IE, IN, IT, JP, MY, NL, NO, TW |
| Model numbers | 861388, 861389 |
Product
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. 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 defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) 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.
Reason for recall
Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.