Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation
Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a life-saving medical device potentially failing to function during a cardiac emergency, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems North America Inc. is recalling the HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The recall involves 251 units distributed worldwide, including 128 units in the United States and 123 units in other countries.
The recall is issued 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. If this separation occurs, the AED may not be ready to deliver a shock in the event of an emergency. The HeartStart FR3 is designed for use by trained responders to treat suspected victims of ventricular fibrillation and certain ventricular tachycardias.
Affected units are identified by specific serial numbers listed in the official recall notice. Users should check the serial number of their device against the provided list. If the device is affected, users should contact Philips for instructions on repair or replacement.
The recalled product
- 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)
- Manufacturer
- Philips Medical Systems North America Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers of units distributed in the USA: C13A-00592
- C13C-00131
- C13C-00150
- C13C-00270
- C13C-00679
- C13C-00681
- C13C-00769
- C13D-00048
- C13D-00197
- C13E-00088
- C13E-00168
- C13E-00234
- C13E-00242
- C13E-00245
- C13E-00326
- C13E-00340
- C13E-00368
- C13E-00372
- C13E-00380
- C13E-00382
Distribution
Related recalls
Same manufacturer · Philips Medical Systems North America Inc.
See all →- HighPhilips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue
FDA (Devices) · 2014-03-26
- HighPhilips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings
FDA (Devices) · 2014-03-26
- HighPhilips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings
FDA (Devices) · 2014-03-26
- ModeratePhilips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors
FDA (Devices) · 2013-11-27
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12