Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).

Class I - Dangerous

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    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, A13G-00081, A13G-00082, A13G-00083, A13G-00084, A13G-00085, A13G-00086, A13G-00087, A13G-00088, A13G-00089, A13G-00090, A13G-00091, A13G-00092, A13G-00093, A13G-00095, A13G-00096, A13G-00097, A13G-00098, A13G-00099, A13G-00100, A13G-00101, A13G-00102, A13G-00103, A13G-00104, A13G-00105, A13G-00106, A13G-00107, A13G-00108, A13G-00109, A13G-00110, A13G-00111, A13G-00112, A13G-00114, A13G-00115, A13G-00116, A13G-00117, A13G-00118, A13G-00119, A13G-00120, A13G-00122, A13G-00123, A13G-00124, A13G-00125, A13G-00126, A13G-00127, A13G-00128, A13G-00129, A13G-00130, A13G-00131, A13G-00132, A13G-00133, A13G-00134, A13G-00135, A13G-00136, A13G-00137, A13G-00138, A13G-00139, A13G-00140, A13G-00141, A13G-00142, A13G-00143, A13G-00144, A13G-00145, A13G-00146, A13G-00147, A13G-00148, A13G-00149, A13G-00150, A13G-00151, A13G-00152, A13G-00153, A13G-00154, A13G-00155, A13G-00156, A13G-00157, A13G-00158, A13G-00159, A13G-00160, A13G-00161, A13G-00162, A13G-00163, A13G-00164, A13G-00165, A13G-00166, A13G-00167, A13G-00168, A13G-00169, A13G-00170, A13G-00171, A13G-00172, A13G-00173, A13G-00174, A13G-00175, A13G-00176, A13G-00177, A13G-00178, A13G-00179, A13G-00180, A13G-00181, A13G-00182, A13G-00183, A13G-00184, A13G-00185, A13G-00186, A13G-00187, A13G-00188, A13G-00189, A13G-00190, A13G-00192, A13G-00193, A13G-00194, A13G-00195, A13G-00196, A13G-00197, A13G-00198, A13G-00199, A13G-00201, A13G-00202, A13G-00204, A13G-00215, A13G-00222, A13G-00223, A13G-00258, A13G-00259, A13G-00260, A13G-00261, A13G-00262, A13G-00263, A13G-00264, A13G-00265, A13G-00277, A13G-00288, A13G-00289, A13G-00294, A13G-00325, A13G-00336, A13G-00337, A13G-00338, A13G-00339, A13G-00340, A13G-00341, A13G-00342, A13G-00343, A13G-00344, A13G-00345, A13G-00355, A13G-00356, A13G-00359, A13G-00375, A13G-00376, A13G-00377, A13G-00378, A13G-00379, A13G-00380, A13G-00381, A13G-00403, A13G-00404, A13G-00406, A13G-00407, A13G-00408, A13G-00409, A13G-00410, A13G-00415, A13G-00417, A13G-00418, A13G-00419, A13G-00420, 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A13G-01046, A13G-01047, A13G-01048, A13G-01049, A13G-01050, A13G-01051, A13G-01052, A13G-01053, A13G-01054, A13G-01055, A13G-01056, A13G-01057, A13G-01058, A13G-01059, A13G-01060, A13G-01061, A13G-01062, A13G-01063, A13G-01064, A13G-01065, A13G-01066, A13G-01067, A13G-01068, A13G-01069, A13G-01070, A13G-01072, A13G-01074, A13G-01077, A13G-01081, A13G-01086, A13G-01088, A13G-01090, A13G-01093, A13G-01107, A13G-01108, A13G-01109, A13G-01110, A13G-01111, A13G-01113, A13G-01131, A13G-01134, A13G-01136, A13G-01137, A13G-01138, A13G-01139, A13G-01140, A13G-01141, A13G-01142, A13G-01143, A13G-01144, A13G-01145, A13G-01146, A13G-01147, A13G-01148, A13G-01149, A13G-01150, A13G-01151, A13G-01152, A13G-01153, A13G-01154, A13G-01155, A13G-01156, A13G-01157, A13G-01158, A13G-01159, A13G-01160, A13G-01161, A13G-01162, A13G-01163, A13G-01164, A13G-01165, A13G-01167, A13G-01168, A13G-01169, A13G-01170, A13G-01171, A13G-01172, A13G-01173, A13G-01174, A13G-01175, A13G-01176, A13G-01177, A13G-01178, A13G-01179, A13G-01180, A13G-01181, A13G-01182, A13G-01184, A13G-01185, A13G-01186, A13G-01187, A13G-01188, A13G-01189, A13G-01190, A13G-01191, A13G-01192, A13G-01193, A13G-01194, A13G-01195, A13G-01196, A13G-01197, A13G-01198, A13G-01199, A13G-01201, A13G-01202, A13G-01203, A13G-01204, A13G-01205, A13G-01207, A13G-01208, A13G-01209, A13G-01210, A13G-01211, A13G-01212, A13G-01213, A13G-01214, A13G-01215, A13G-01216, A13G-01217, A13G-01218, A13G-01219, A13G-01220, A13G-01221, A13G-01222, A13G-01223, A13G-01224, A13G-01225, A13G-01226, A13G-01227, A13G-01228, A13G-01229, A13G-01230, A13G-01231, A13G-01232, A13G-01233, A13G-01234, A13G-01235, A13G-01236, A13G-01237, A13G-01238, A13G-01239, A13G-01240, A13G-01241, A13G-01242, A13G-01243, A13G-01244, A13G-01245, A13G-01246, A13G-01247, A13G-01248, A13G-01249, A13G-01250, A13G-01251, A13G-01252, A13G-01253, A13G-01254, A13G-01255, A13G-01256, A13G-01257, A13G-01258, A13G-01259, A13G-01260, A13G-01261, A13G-01262, A13G-01263, A13G-01264, A13G-01265, A13G-01266, A13G-01267, A13G-01268, A13G-01269, A13G-01270, A13G-01271, A13G-01272, A13G-01273, A13G-01274, A13G-01275, A13G-01276, A13G-01277, A13G-01278, A13G-01279, A13G-01280, A13G-01281, A13G-01282, A13G-01284, A13G-01285, A13G-01286, A13G-01287, A13G-01288, A13G-01289, A13G-01290, A13G-01291, A13G-01292, A13G-01293, A13G-01294, A13G-01296, A13G-01297, A13G-01298, A13G-01299, A13G-01300, A13G-01301, A13G-01302, A13G-01303, A13G-01304, A13G-01305, A13G-01306, A13G-01307, A13G-01308, A13G-01309, A13G-01310, A13G-01311, A13G-01312, A13G-01313, A13G-01314, A13G-01315, A13G-01316, A13G-01317, A13G-01318, A13G-01319, A13G-01320, A13G-01321, A13G-01322, A13G-01323, A13G-01324, A13G-01325, A13G-01326, A13G-01327, A13G-01328, A13G-01329, A13G-01330, A13G-01331, A13G-01332, A13G-01333, A13G-01334, A13G-01335, A13G-01336, A13G-01337, A13G-01338, A13G-01339, A13G-01340, A13G-01341, A13G-01342, A13G-01343, A13G-01344, A13G-01345, A13G-01346, A13G-01347, A13G-01348, A13G-01349, A13G-01350, A13G-01351, A13G-01352, A13G-01353, A13G-01354, A13G-01355, A13G-01356, A13G-01357, A13G-01358, A13G-01359, A13G-01360, A13G-01361, A13G-01362, A13G-01363, A13G-01364, A13G-01365, A13G-01366, A13G-01367, A13G-01368, A13G-01369, A13G-01370, A13G-01371, A13G-01372, A13G-01373, A13G-01374, A13G-01375, A13G-01376, A13G-01377, A13G-01378, A13G-01379, A13G-01380, A13G-01381, A13G-01382, A13G-01383, A13G-01384, A13G-01385, A13G-01386, A13G-01387, A13G-01388, A13G-01389, A13G-01390, A13G-01391, A13G-01392, A13G-01393, A13G-01394, A13G-01395, A13G-01397, A13G-01398, A13G-01399, A13G-01401, A13G-01402, A13G-01403, A13G-01404, A13G-01405, A13G-01406, A13G-01407, A13G-01408, A13G-01409, A13G-01410, A13G-01411, A13G-01412, A13G-01413, A13G-01414, A13G-01415, A13G-01416, A13G-01417, A13G-01418, A13G-01419, A13G-01420, A13G-01421, A13G-01423, A13G-01424, A13G-01425, A13G-01426, A13G-01427, A13G-01428, A13G-01429, A13G-01430, A13G-01431, A13G-01432, A13G-01433, A13G-01434, A13G-01435, 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A13G-04573, A13G-04574, A13G-04575, A13G-04593, A13G-04594, A13G-04595, A13G-04601, A13G-04602, A13G-04603, A13G-04604, A13G-04605, A13G-04606, A13G-04607, A13G-04609, A13G-04610, A13G-05031, A13G-05034, A13G-05035, A13G-05055, A13G-05057, A13G-05059, A13G-05067, A13G-05068, A13G-05069, A13G-05070, A13G-05071, A13G-05073, A13G-05081, A13G-05082, A13G-05083, A13G-05084, A13G-05085, A13G-05090, A13G-05151, A13G-05152, A13G-05153, A13G-05154, A13G-05155, A13G-05156, A13G-05157, A13G-05158, A13G-05160, A13G-05161, A13G-05162, A13G-05163, A13G-05164, A13G-05165, A13G-05166, A13G-05167, A13G-05168, A13G-05169, A13G-05170, A13G-05171, A13G-05172, A13G-05173, A13G-05174, A13G-05180, A13G-05197, A13G-05198, A13G-05199, A13G-05201, A13G-05202, A13G-05203, A13G-05205, A13G-05212, A13G-05214, A13G-05215, A13G-05218, A13G-05221, A13G-05224, A13G-05225, A13G-05227, A13G-05228, A13G-05229, A13G-05230, A13G-05234, A13G-05235, A13G-05236, A13G-05237, A13G-05238, A13G-05239, A13G-05242, A13G-05246, A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, 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A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in 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 Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).

Product Codes/Lot Numbers:

SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, 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A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, 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A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1232-2014

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