Class 1 Device Recall Powerheart 9300C automated external defibrillator

• Date Initiated by Firm: November 13, 2009
• Date Posted: March 04, 2010
• Recall Status: Terminated on October 24, 2014
• Recall Number: Z-0766-2010
• Recall Event ID: 53827
• 510(K)Number: K031987 K040438 K052161
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).; ; Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
• Code Information: SERIAL NUMBERS: 330941, 330942, 330944, 330945, 330947, 330948, 330950, 330951, 330952, 330954, 330956, 330957, 330958, 330959, 330960, 330962, 330963, 330964, 330965, 330966, 330967, 330968, 330969, 330970, 330972, 330973, 330975, 330976, 330977, 330978, 330979, 330980, 330981, 330983, 330985, 330986, 330987, 330988, 330989, 330990, 330992, 330993, 330994, 330995, 330996, 330997, 330998, 330999, 331001, 331002, 331004, 331005, 331006, 331009, 331010, 331011, 331012, 331013, 331016, 331017, 331018, 331019, 331020, 331261, 331262, 331263, 331266, 331267, 331268, 331269, 331270, 331271, 331272, 331273, 331274, 331275, 331277, 331280, 331281, 331282, 331283, 331284, 331285, 331286, 331287, 331288, 331289, 331290, 331291, 331292, 331293, 331294, 331295, 331296, 331297, 331298, 331299, 331300, 331301, 331302, 331303, 331304, 331305, 331306, 331307, 331308, 331310, 331311, 331312, 331313, 331315, 331316, 331319, 331320, 331321, 331322, 331323, 331325, 331326, 331328, 331329, 331330, 331331, 331332, 331333, 331334, 331336, 331337, 331338, 331339, 331340, 332181, 332182, 332183, 332184, 332185, 332186, 332187, 332189, 332190, 332191, 332192, 332193, 332194, 332195, 332196, 332197, 332198, 332199, 332200, 332201, 332202, 332203, 332204, 332206, 332207, 332208, 332209, 332210, 332211, 332212, 332213, 332214, 332215, 332216, 332217, 332218, 332219, 332220, 332221, 332222, 332223, 332224, 332225, 332226, 332227, 332228, 332229, 332230, 332231, 332232, 332233, 332234, 332235, 332236, 332237, 332238, 332239, 332240, 332241, 332242, 332243, 332244, 332245, 332246, 332247, 332249, 332250, 332251, 332252, 332253, 332254, 332255, 332256, 332257, 332258, 332259, 332260, 332261, 332262, 332263, 332264, 332266, 332267, 332268, 332269, 332270, 332271, 332273, 332274, 332275, 332276, 332277, 332278, 332281, 332284, 332285, 332286, 332287, 332288, 332290, 332291, 332292, 332293, 332295, 332296, 332297, 332298, 332299, 332300, 332302, 332303, 332304, 332305, 332306, 332307, 332309, 332310, 332311, 332313, 332314, 332315, 332316, 332318, 332319, 332320, 332321, 332323, 332324, 332325, 332327, 332328, 332329, 332330, 332331, 332332, 332333, 332334, 332335, 332336, 332337, 332338, 332339, 332340, 332341, 332342, 332343, 332344, 332345, 332346, 332347, 332348, 332349, 332350, 332351, 332352, 332353, 332354, 332355, 332356, 332357, 332358, 332359, 332360, 332361, 332362, 332363, 332364, 332365, 332366, 332367, 332368, 332369, 332370, 332371, 332372, 332373, 332374, 332375, 332377, 332378, 332379, 332380, 332381, 332382, 332383, 332384, 332385, 332386, 332387, 332389, 332390, 332391, 332392, 332393, 332394, 332395, 332396, 332397, 332398, 332399, 332400, 332401, 332402, 332403, 332404, 332405, 332406, 332407, 332408, 332409, 332410, 332411, 332412, 332413, 332414, 332415, 332416, 332417, 332418, 332419, 332420, 333156, 334381, 334382, 334383, 334384, 334385, 334386, 334387, 334388, 334389, 334390, 334391, 334392, 334393, 334394, 334395, 334396, 334397, 334398, 334399, 334400, 334401, 334403, 334404, 334405, 334406, 334407, 334408, 334409, 334410, 334411, 334412, 334413, 334414, 334415, 334416, 334417, 334418, 334419, 334420, 334421, 334422, 334423, 334424, 334425, 334426, 334427, 334428, 334429, 334430, 334431, 334432, 334433, 334434, 334435, 334436, 334437, 334438, 334439, 334440, 334441, 334442, 334443, 334444, 334445, 334446, 334447, 334448, 334449, 334450, 334451, 334452, 334453, 334454, 334455, 334456, 334457, 334458, 334459, 334460, 334461, 334462, 334463, 334464, 334465, 334466, 334467, 334468, 334469, 334470, 334471, 334472, 334473, 334474, 334475, 334476, 334477, 334478, 334479, 334480, 334481, 334482, 334483, 334484, 334485, 334486, 334488, 334489, 334490, 334491, 334492, 334493, 334494, 334496, 334497, 334498, 334499, 334500, 334501, 334502, 334503, 334504, 334505, 334506, 334507, 334509, 334510, 334512, 334513, 334514, 334515, 334516, 334517, 334518, 334519, 334520, 334521, 334522, 334523, 334524, 334525, 334526, 334527, 334528, 334529, 334530.334531, 334532, 334535, 334536, 334537, 334538, 334539, 334540, 334901, 334902, 334903, 334904, 334905, 334906, 334907, 334908, 334909, 334910, 334911, 334912, 334913, 334914, 334915, 334916, 334917, 334918, 334919, 334920, 334921, 334922, 334923, 334924, 334925, 334926, 334927, 334928, 334929, 334930, 334931, 334932, 334934, 334935, 334936, 334937, 334938, 334939, 334940, 334941, 334942, 334943, 334944, 334945, 334946, 334947, 334948, 334949, 334950, 334951, 334952, 334953, 334954, 334955, 334956, 334957, 334958, 334959, 334960, 334961, 334962, 334963, 334964, 334965, 334966, 334967, 334968, 334969, 334971, 334972, 334973, 334974, 334975, 334976, 334977, 334978, 334979, 334980, 334981, 334982, 334983, 334984, 334985, 334986, 334987, 334989, 334990, 334991, 334992, 334994, 334995, 334996, 334997, 334998, 334999, 335000, 335001, 335002, 335003, 335004, 335005, 335006, 335007, 335008, 335009, 335010, 335011, 335012, 335013, 335014, 335015, 335016, 335018, 335019, 335020, 335021, 335022, 335023, 335024, 335025, 335026, 335027, 335028, 335029, 335030, 335031, 335032, 335034, 335035, 335036, 335038, 335039, 335041, 335042, 335043, 335045, 335046, 335047, 335048, 335050, 335051, 335052, 335053, 335056, 335058, 335059, 335060, 335062, 335063, 335064, 335065, 335066, 335067, 335068, 335069, 335070, 335071, 335072, 335073, 335074, 335075, 335076, 335077, 335078, 335079, 335082, 335083, 335084, 335086, 335087, 335088, 335089, 335090, 335091, 335092, 335093, 335094, 335095, 335096, 335097, 335098, 335099, 335100, 335101, 335102, 335103, 335104, 335105, 335106, 335107, 335108, 335109, 335110, 335111, 335112, 335113, 335114, 335115, 335116, 335117, 335119, 335120, 335121, 335122, 335123, 335124, 335125, 335126, 335128, 335129, 335130, 335131, 335132, 335133, 335134, 335135, 335136, 335137, 335138, 335139, 335141, 335142, 335143, 335144, 335145, 335146, 335147, 335148, 335149, 335150, 335151, 335152, 335153, 335154, 335155, 335156, 335157, 335158, 335159, 335160, 335161, 335162, 335164, 335165, 335166, 335167, 335168, 335169, 335170, 335171, 335173, 335175, 335176, 335177, 335178, 335179, 335180, 335181, 335184, 335186, 335187, 335188, 335189, 335190, 335191, 335192, 335193, 335194, 335195, 335196, 335197, 335198, 335199, 335200, 335201, 335202, 335203, 335204, 335205, 335206, 335207, 335208, 335209, 335210, 335212, 335213, 335214, 335215, 335216, 335217, 335218, 335219, 335220, 335221, 335222, 335223, 335225, 335226, 335227, 335228, 335229, 335230, 335231, 335232, 335233, 335234, 335235, 335236, 335237, 335238, 335239, 335240, 335241, 335242, 335243, 335244, 335245, 335248, 335249, 335250, 335251, 335252, 335253, 335254, 335255, 335256, 335257, 335259, 335260, 335261, 335262, 335263, 335264, 335265, 335266, 335267, 335268, 335269, 335270, 335271, 335272, 335273, 335274, 335275, 335276, 335277, 335278, 335279, 335280, 335281, 335282, 335283, 335284, 335286, 335287, 335288, 335289, 335290, 335291, 335292, 335293, 335294, 335295, 335296, 335297, 335298, 335299, 335300, 335301, 335302, 335303, 335304, 335305, 335307, 335308, 335309, 335310, 335311, 335312, 335313, 335314, 335315, 335316, 335317, 335319, 335320, 335321, 335322, 335323, 335324, 335326, 335327, 335328, 335329, 335330, 335331, 335332, 335333, 335334, 335335, 335337, 335338, 335339, 335341, 335342, 335343, 335344, 335345, 335346, 335347, 335348, 335349, 335350, 335351, 335353, 335354, 335355, 335356, 335357, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335366, 335368, 335369, 335371, 335372, 335374, 335375, 335376, 335377, 335378, 335379, 335380, 335381, 335382, 335383, 335385, 335386, 335387, 335388, 335389, 335390, 335391, 335392, 335393, 335395, 335396, 335397, 335398, 335399, 335400, 335401, 335402, 335403, 335404, 335405, 335406, 335407, 335408, 335409, 335410, 335411, 335412, 335414, 335415, 335416, 335417, 335418, 335420, 335421, 335422, 335423, 335424, 335425, 335426, 335427, 335428, 335429, 335430, 335431, 335432, 335433, 335434, 335436, 335438, 335439, 335440.335441, 335442, 335443, 335444, 335445, 335446, 335447, 335448, 335450, 335451, 335452, 335453, 335454, 335455, 335456, 335458, 335460, 337927, 337981, 337982, 337983, 337984, 337985, 337986, 337988, 337989, 337990, 337991, 337992, 337993, 337994, 337995, 337996, 337998, 338000, 338001, 338003, 338004, 338005, 338006, 338007, 338008, 338009, 338010, 338011, 338012, 338013, 338014, 338015, 338016, 338019, 338021, 338022, 338023, 338025, 338026, 338028, 338029, 338030, 338032, 338033, 338034, 338036, 338037, 338038, 338040, 338042, 338043, 338044, 338046, 338047, 338048, 338049, 338051, 338052, 338054, 338055, 338056, 338057, 338058, 338061, 338063, 338064, 338065, 338066, 338067, 338068, 338069, 338070, 338071, 338074, 338076, 338077, 338080, 338082, 338083, 338085, 338086, 338089, 338090, 338092, 338093, 338094, 338096, 338097, 338098, 338099, 338100, 338101, 338102, 338104, 338105, 338106, 338107, 338109, 338110, 338111, 338112, 338114, 338115, 338116, 338118, 338119, 338120, 338122, 338123, 338124, 338126, 338127, 338128, 338129, 338131, 338132, 338133, 338135, 338136, 338137, 338138, 338139, 338141, 338143, 338144, 338145, 338146, 338147, 338150, 338151, 338153, 338154, 338155, 338157, 338158, 338159, 338160, 338162, 338164, 338165, 338166, 338167, 338168, 338169, 338170, 338171, 338172, 338173, 338174, 338175, 338176, 338177, 338178, 338179, 338180, 338181, 338182, 338183, 338184, 338185, 338186, 338187, 338188, 338189, 338190, 338191, 338192, 338193, 338195, 338196, 338197, 338198, 338199, 338200, 338201, 338202, 338203, 338204, 338205, 338206, 338207, 338208, 338209, 338210, 338211, 338213, 338214, 338215, 338216, 338219, 338220, 338221, 338222, 338223, 338224, 338225, 338226, 338227, 338228, 338229, 338230, 338231, 338232, 338233, 338234, 338235, 338236, 338237, 338238, 338239, 338240, 338241, 338242, 338243, 338244, 338245, 338246, 338247, 338249, 338250, 338251, 338252, 338254, 338255, 338256, 338258, 338259, 338260, 338261, 338262, 338263, 338264, 338265, 338266, 338267, 338268, 338269, 338270, 338271, 338272, 338273, 338274, 338275, 338276, 338277, 338278, 338279, 338280, 338281, 338282, 338283, 338284, 338285, 338287, 338288, 338289, 338290, 338291, 338292, 338293, 338294, 338295, 338296, 338297, 338298, 338299, 338300, 338301, 338302, 338303, 338304, 338305, 338306, 338307, 338308, 338309, 338310, 338311, 338312, 338313, 338314, 338315, 338316, 338317, 338318, 338319, 338321, 338322, 338323, 338324, 338325, 338326, 338327, 338328, 338329, 338330, 338331, 338332, 338333, 338334, 338335, 338336, 338337, 338338, 338339, 338340, 338341, 338342, 338343, 338344, 338345, 338346, 338347, 338348, 338349, 338351, 338352, 338353, 338354, 338355, 338356, 338357, 338358, 338359, 338360, 338361, 338362, 338363, 338364, 338365, 338366, 338367, 338368, 338369, 338370, 338371, 338372, 338373, 338374, 338375, 338376, 338377, 338378, 338379, 338380, 338381, 338382, 338383, 338385, 338386, 338387, 338388, 338389, 338390, 338392, 338393, 338394, 338395, 338396, 338397, 338398, 338399, 338400, 338401, 338402, 338403, 338404, 338405, 338406, 338408, 338409, 338410, 338411, 338413, 338414, 338415, 338417, 338418, 338419, 338420, 338421, 338423, 338424, 338425, 338426, 338427, 338428, 338429, 338430, 338431, 338433, 338434, 338435, 338436, 338437, 338438, 338439, 338440, 338442, 338443, 338444, 338445, 338446, 338447, 338448, 338449, 338450, 338451, 338453, 338454, 338455, 338456, 338457, 338458, 338459, 338460, 338461, 338463, 338464, 338465, 338466, 338467, 338468, 338470, 338471, 338472, 338474, 338476, 338477, 338478, 338479, 338480, 338481, 338482, 338483, 338484, 338485, 338486, 338487, 338488, 338489, 338490, 338491, 338492, 338493, 338494, 338495, 338497, 338498, 338499, 338500, 338501, 338503, 338504, 338505, 338507, 338508, 338509, 338510, 338511, 338512, 338513, 338514, 338515, 338516, 338517, 338518, 338519, 338520, 338521, 338522, 338523, 338524, 338525, 338526, 338529, 338530, 338531, 338532, 338533, 338534, 338535, 338536.338538, 338539, 338540, 338861, 338862, 338863, 338864, 338865, 338866, 338867, 338870, 338871, 338872, 338873, 338875, 338876, 338877, 338878, 338879, 338880, 338881, 338882, 338883, 338884, 338885, 338886, 338887, 338888, 338890, 338891, 338892, 338893, 338894, 338895, 338897, 338898, 338899, 338900, 338902, 338904, 338905, 338906, 338907, 338908, 338909, 338910, 338911, 338912, 338913, 338914, 338915, 338917, 338918, 338919, 338920, 338921, 338922, 338923, 338924, 338925, 338926, 338927, 338928, 338929, 338930, 338931, 338932, 338933, 338934, 338935, 338936, 338937, 338938, 338939, 340221, 340222, 340223, 340225, 340226, 340227, 340228, 340229, 340230, 340231, 340232, 340233, 340234, 340235, 340236, 340237, 340238, 340239, 340240, 340241, 340242, 340244, 340245, 340246, 340247, 340248, 340249, 340250, 340251, 340252, 340253, 340254, 340256, 340257, 340258, 340259, 340260, 340261, 340262, 340264, 340265, 340266, 340267, 340268, 340269, 340270, 340271, 340272, 340274, 340276, 340277, 340278, 340279, 340280, 340281, 340282, 340283, 340284, 340285, 340286, 340287, 340288, 340289, 340290, 340292, 340293, 340294, 340295, 340296, 340297, 340298, 340299, 340300, 340301, 340303, 340304, 340305, 340307, 340308, 340309, 340310, 340311, 340313, 340314, 340315, 340316, 340317, 340318, 340319, 340320, 340321, 340322, 340323, 340324, 340325, 340326, 340327, 340328, 340329, 340330, 340331, 340332, 340333, 340334, 340335, 340336, 340339, 340340, 340341, 340342, 340343, 340344, 340345, 340346, 340347, 340348, 340349, 340351, 340352, 340353, 340355, 340356, 340357, 340358, 340359, 340360, 340361, 340362, 340363, 340364, 340366, 340367, 340368, 340369, 340371, 340372, 340373, 340374, 340375, 340377, 340378, 340379, 340380, 341261, 341262, 341264, 341265, 341266, 341267, 341268, 341270, 341271, 341272, 341273, 341274, 341275, 341276, 341277, 341278, 341280, 341281, 341282, 341283, 341284, 341285, 341286, 341287, 341288, 341289, 341290, 341291, 341292, 341293, 341294, 341295, 341296, 341297, 341298, 341299, 341300, 341301, 341302, 341304, 341307, 341308, 341309, 341310, 341311, 341313, 341314, 341315, 341317, 341320, 341321, 341322, 341323, 341324, 341325, 341326, 341327, 341328, 341329, 341330, 341331, 341332, 341333, 341334, 341335, 341336, 341337, 341338, 341339, 341340, 341341, 341342, 341343, 341344, 341345, 341346, 341347, 341349, 341350, 341351, 341352, 341353, 341354, 341355, 341356, 341357, 341358, 341359, 341360, 341361, 341362, 341363, 341364, 341365, 341366, 341367, 341368, 341369, 341370, 341371, 341372, 341373, 341374, 341375, 341376, 341377, 341378, 341379, 341380, 341381, 341382, 341383, 341384, 341385, 341386, 341387, 341388, 341389, 341390, 341391, 341392, 341393, 341394, 341395, 341396, 341397, 341398, 341399, 341400, 341401, 341403, 341405, 341406, 341407, 341408, 341409, 341410, 341411, 341412, 341413, 341414, 341415, 341416, 341417, 341419, 341420, 341421, 341423, 341424, 341425, 341426, 341427, 341428, 341429, 341432, 341433, 341435, 341436, 341437, 341438, 341439, 341440, 341441, 341442, 341443, 341444, 341446, 341447, 341448, 341450, 341451, 341452, 341453, 341454, 341455, 341456, 341457, 341458, 341459, 341460, 341461, 341462, 341463, 341464, 341466, 341467, 341468, 341469, 341470, 341471, 341472, 341473, 341474, 341475, 341476, 341477, 341478, 341479, 341480, 341481, 341482, 341483, 341484, 341486, 341487, 341488, 341489, 341490, 341491, 341492, 341493, 341494, 341495, 341498, 341499, 341500, 341503, 341504, 341506, 341507, 341508, 341509, 341510, 341512, 341513, 341514, 341515, 341516, 341517, 341520, 341521, 341522, 341523, 341524, 341525, 341526, 341527, 341528, 341529, 341530, 341531, 341532, 341533, 341535, 341536, 341537, 341538, 341539, 341540, 341541, 341543, 341544, 341545, 341546, 341547, 341550, 341551, 341552, 341553, 341554, 341555, 341556, 341557, 341558, 341559, 341560, 341561, 341562, 341563, 341564, 341565, 341568, 341569, 341570, 341571, 341572, 341573, 341574, 341575, 341576, 341577, 341578, 341579.341580, 341661, 341662, 341663, 341664, 341665, 341666, 341667, 341668, 341669, 341670, 341671, 341672, 341674, 341675, 341676, 341677, 341678, 341679, 341680, 341681, 341682, 341684, 341685, 341686, 341687, 341688, 341689, 341690, 341692, 341693, 341695, 341696, 341697, 341698, 341699, 341700, 341701, 341702, 341704, 341705, 341707, 341708, 341709, 341710, 341711, 341712, 341713, 341714, 341715, 341716, 341718, 341719, 341720, 341721, 341723, 341724, 341725, 341727, 341728, 341730, 341731, 341733, 341734, 341735, 341736, 341737, 341739, 341740, 341741, 341742, 341743, 341744, 341746, 341747, 341748, 341751, 341752, 341753, 341754, 341756, 341757, 341758, 341759, 341760, 341761, 341762, 341763, 341764, 341765, 341766, 341767, 341769, 341770, 341771, 341772, 341773, 341774, 341775, 341776, 341777, 341779, 341781, 341783, 341784, 341785, 341786, 341788, 341789, 341793, 341794, 341795, 341796, 341797, 341798, 341799, 341800, 341803, 341804, 341807, 341808, 341809, 341810, 341811, 341812, 341814, 341815, 341816, 341817, 341819, 341823, 341824, 341825, 341826, 341828, 341829, 341830, 341831, 341832, 341833, 341834, 341835, 341837, 341838, 341839, 341840, 341841, 341843, 341845, 341846, 341847, 341848, 341849, 341850, 341851, 341852, 341853, 341855, 341856, 341857, 341858, 341859, 341860, 341861, 341862, 341863, 341864, 341866, 341867, 341868, 341869, 341872, 341873, 341875, 341876, 341878, 341879, 341880, 341881, 341885, 341886, 341887, 341889, 341892, 341893, 341894, 341895, 341896, 341897, 341898, 341900, 341902, 341904, 341905, 341906, 341907, 341909, 341910, 341911, 341913, 341914, 341915, 341916, 341917, 341918, 341919, 341920, 341921, 341922, 341924, 341925, 341926, 341927, 341928, 341929, 341930, 341931, 341932, 341933, 341935, 341936, 341937, 341938, 341939, 341940, 341941, 341942, 341943, 341945, 341946, 341947, 341948, 341949, 341950, 341951, 341952, 341953, 341954, 341955, 341956, 341957, 341958, 341959, 341960, 341961, 341962, 341963, 341964, 341965, 341967, 341968, 341969, 341970, 341971, 341972, 341973, 341974, 341976, 341977, 341978, 341979, 341980, 341982, 341983, 341984, 341985, 341986, 341987, 341988, 341989, 341990, 341991, 341992, 341993, 341995, 341996, 341997, 341998, 341999, 342000, 342001, 342002, 342003, 342004, 342005, 342006, 342007, 342008, 342009, 342010, 342011, 342012, 342013, 342014, 342015, 342016, 342018, 342019, 342021, 342022, 342023, 342024, 342025, 342027, 342028, 342029, 342030, 342031, 342032, 342033, 342034, 342035, 342036, 342037, 342038, 342039, 342040, 342041, 342042, 342044, 342045, 342046, 342047, 342048, 342049, 342050, 342051, 342052, 342053, 342054, 342055, 342056, 342057, 342058, 342059, 342060, 346381, 346382, 346383, 346384, 346386, 346387, 346388, 346389, 346390, 346391, 346392, 346393, 346394, 346396, 346397, 346398, 346399, 346400, 346401, 346402, 346403, 346404, 346405, 346406, 346407, 346408, 346409, 346410, 346411, 346412, 346413, 346414, 346415, 346416, 346417, 346418, 346419, 346420, 346421, 346422, 346423, 346424, 346425, 346426, 346427, 346428, 346429, 346430, 346431, 346432, 346433, 346434, 346435, 346436, 346437, 346438, 346439, 346440, 346441, 346442, 346443, 346444, 346445, 346446, 346447, 346448, 346449, 346450, 346451, 346452, 346453, 346454, 346455, 346456, 346457, 346458, 346459, 346460, 346461, 346462, 346463, 346464, 346465, 346466, 346468, 346469, 346470, 346471, 346472, 346473, 346474, 346475, 346476, 346477, 346478, 346479, 346480, 346481, 346482, 346483, 346484, 346485, 346486, 346487, 346488, 346489, 346490, 346491, 346492, 346493, 346494, 346495, 346496, 346497, 346498, 346499, 346500, 346501, 346502, 346503, 346504, 346505, 346506, 346507, 346508, 346509, 346510, 346511, 346512, 346513, 346514, 346515, 346516, 346517, 346519, 346520, 346521, 346522, 346523, 346524, 346526, 346527, 346528, 346529, 346530, 346531, 346532, 346533, 346534, 346535, 346536, 346537, 346538, 346539, 346540, 351358, 366557, 366580, 366623, 366629, 366654, 377310, 379288, 381684.381685, 381686, 381687, 381688, 381689, 381690, 381691, 381692, 381693, 381694, 381695, 381696, 381697, 381698, 381699, 381700, 381701, 381702, 381703, 381704, 381705, 381706, 381707, 381708, 381709, 381710, 381711, 381712, 381713, 381714, 381715, 381716, 381717, 381718, 381719, 381720, 381721, 381722, 381723, 381725, 381726, 381728, 381730, 381731, 381732, 381733, 381734, 381735, 381736, 381737, 381738, 381739, 381740, 381741, 381742, 381743, 382777, 382944, 382945, 382946, 382947, 382948, 382949, 382951, 382952, 382953, 382954, 382955, 382956, 382957, 382958, 382959, 382960, 382962, 382963, 382964, 382965, 382966, 382967, 382968, 382969, 382970, 382971, 382972, 382973, 382974, 382975, 382976, 382977, 382978, 382979, 382980, 382981, 382982, 382983, 382984, 382985, 382986, 382987, 382988, 382989, 382990, 382992, 382993, 382994, 382995, 382996, 382997, 382998, 382999, 383000, 383001, 383002, 383003, 383004, 383005, 383006, 383008, 383009, 383010, 383011, 383012, 383013, 383014, 383015, 383016, 383017, 383018, 383019, 383020, 383021, 383022, 383023, 383024, 383025, 383026, 383027, 383028, 383029, 383030, 383031, 383032, 383033, 383034, 383035, 383036, 383037, 383038, 383039, 383040, 383041, 383043, 384354, 384355, 384356, 384357, 384358, 384359, 384360, 384361, 384362, 384363, 384364, 384365, 384366, 384367, 384368, 384369, 384370, 384372, 384373, 384374, 384375, 384376, 384377, 384378, 384379, 384380, 384381, 384382, 384383, 384384, 384385, 384386, 384387, 384388, 384389, 384390, 384391, 384392, 384393, 384394, 384395, 384396, 384397, 384398, 384399, 384400, 384401, 384402, 384403, 388344, 388345, 388347, 388348, 388349, 388350, 388351, 388352, 388353, 388354, 388355, 388357, 388358, 388359, 388360, 388361, 388362, 388363, 388364, 388367, 388368, 388369, 388370, 388371, 388372, 388373, 388374, 388375, 388376, 388377, 388378, 388379, 388380, 388381, 388382, 388383, 388384, 388385, 388386, 388387, 388388, 388389, 388390, 388391, 388392, 388393, 388394, 388395, 388396, 388397, 388398, 388399, 388400, 388401, 388402, 388403, 388404, 388405, 388406, 388407, 388408, 388409, 388410, 388411, 388412, 388413, 388414, 388415, 388416, 388417, 388418, 388419, 388420, 388421, 388422, 388423, 388424, 388425, 388426, 388427, 388428, 388429, 388430, 388431, 388432, 388433, 388434, 388435, 388436, 388438, 388439, 388440, 388441, 388442, 388443, 391754, 391755, 391756, 391757, 391758, 391760, 391762, 391763, 391764, 391765, 391766, 391767, 391768, 391769, 391771, 391772, 391773, 391774, 391775, 391777, 391778, 391780, 391781, 391782, 391783, 391784, 391786, 391787, 391788, 391789, 391790, 391791, 391793, 391796, 391800, 391801, 391802, 391803, 391804, 391805, 391807, 391809, 391810, 391811, 391812, 391813, 391814, 391815, 391816, 391817, 391818, 391819, 391820, 391821, 391822, 391823, 391824, 391825, 391826, 391827, 391828, 391829, 391831, 391833, 391834, 391835, 391836, 391837, 391838, 391839, 391840, 391841, 391843, 391844, 391845, 391846, 391848, 391849, 391850, 391851 and 391853.
• Recalling Firm/ Manufacturer: Cardiac Science Corporation; 3303 Monte Villa Pkwy; Bothell WA 98021-8969
• For Additional Information Contact: Michael Matysik; 425-402-2206
• Manufacturer Reason for Recall: Potential for devices not to deliver therapy
• FDA Determined Cause: Process control
• Action: Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
• Quantity in Commerce: 3019
• Distribution: Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE; 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE, INC.