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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Medical Systems North America Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1225-2014
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