Devices

Device Recall Powerheart AED

  • Model / Serial
    SERIAL NUMBERS:  4046748, 4171275, 4288092, 4288093, 4288094, 4288095, 4288096, 4288107, 4288108, 4288109, 4288110, 4288111, 4288112, 4288113, 4288114, 4288115, 4288116, 4288117, 4288118, 4288119, 4288155, 4288187, 4288188, 4288189, 4288190, 4288191, 4288192, 4288193, 4288194, 4288195, 4288196, 4288197, 4288198, 4288199, 4288200, 4288201, 4288202, 4288203, 4288204, 4288205, 4288206, 4288207, 4288208, 4288209, 4288281, 4288282, 4288283, 4288284, 4288285, 4288286, 4288287, 4288288, 4288289, 4288290, 4288291, 4288292, 4288293, 4288294, 4288295, 4288296, 4288305, 4288306, 4288312, 4288313, 4288314, 4288316, 4288324, 4288350, 4288351, 4288352, 4288353, 4288354, 4288355, 4288356, 4288357, 4288358, 4288359, 4288360, 4288361, 4288362, 4288363, 4288364, 4288365, 4288366, 4288367, 4288368, 4288369, 4288370, 4288371, 4288372, 4288373, 4288374, 4288375, 4288376, 4288377, 4288378, 4288379, 4288380, 4288381, 4288382, 4288383, 4288384, 4288385, 4288386, 4288387, 4288388, 4288389, 4288390, 4288391, 4288392, 4288393, 4288394, 4288400, 4288401, 4288420, 4288421, 4288422, 4288424, 4288425, 4288426, 4288427, 4288428, 4288429, 4288430, 4288439, 4288440, 4288441, 4288442, 4288443, 4288444, 4288445, 4288447, 4288448, 4288449, 4288450, 4288451, 4288452, 4288453, 4288454, 4288455, 4288456, 4288457, 4288458, 4288459, 4288460, 4288461, 4288462, 4288463, 4288464, 4288465, 4288466, 4288467, 4288468, 4288469, 4288470, 4288471, 4288472, 4288473, 4288474, 4288475, 4288476, 4288477, 4288478, 4288479, 4288480, 4288481, 4288482, 4288483, 4288484, 4288485, 4288486, 4288487, 4288488, 4288489, 4288490, 4288491, 4288492, 4288493, 4288494, 4288495, 4288496, 4288497, 4288498, 4288499, 4288500, 4288501, 4288502, 4288503, 4288504, 4288529, 4288572, 4288573, 4288574, 4288575, 4288576, 4288577, 4288578, 4288579, 4288580, 4288581, 4288582, 4288583, 4288584, 4288585, 4288586, 4288587, 4288588, 4288589, 4288590, 4288591, 4289092, 4289093, 4289094, 4289095, 4289096, 4289097, 4289098, 4289099, 4289100, 4289101, 4289102, 4289103, 4289104, 4289105, 4289107, 4289108, 4289109, 4289110, 4289112, 4289114, 4289115, 4289117, 4289118, 4289119, 4289120, 4289121, 4289122, 4289123, 4289124, 4289128, 4289135, 4289137, 4289139, 4289140, 4289142, 4289143, 4289144, 4289145, 4289149, 4289150, 4289151, 4289152, 4289154, 4289155, 4289156, 4289157, 4289158, 4289159, 4289160, 4289162, 4289166, 4289167, 4289168, 4289169, 4289170, 4289172, 4289173, 4289174, 4289175, 4289176, 4289177, 4289178, 4289212, 4289213, 4289214, 4289216, 4289217, 4289218, 4289220, 4289333, 4289335, 4289341, 4289344, 4289345, 4289346, 4289347, 4289348, 4289349, 4289350, 4289351, 4289352, 4289353, 4289354, 4289355, 4289356, 4289357, 4289359, 4289360, 4289361, 4289362, 4289363, 4289364, 4289365, 4289366, 4289367, 4289368, 4289369, 4289370, 4289371, 4289372, 4289373, 4289374, 4289386, 4289387, 4289388, 4289389, 4289418, 4289435, 4289459, 4289460, 4289461, 4289462, 4289463, 4289464, 4289465, 4289466, 4289467, 4289468, 4289469, 4289471, 4289472, 4289473, 4289475, 4289476, 4289477, 4289478, 4289479, 4289480, 4289481, 4289482, 4289483, 4289484, 4289485, 4289486, 4289487, 4289488, 4289489, 4289490, 4289491, 4289492, 4289493, 4289494, 4289495, 4289496, 4289497, 4289499, 4289500, 4289501, 4289502, 4289503, 4289504, 4289505, 4289506, 4289508, 4289509, 4289510, 4289511, 4289512, 4289513, 4289514, 4289516, 4289517, 4289518, 4289519, 4289520, 4289521, 4289522, 4289523, 4289524, 4289525, 4289526, 4289527, 4289528, 4289529, 4289530, 4289531, 4289532, 4289533, 4289535, 4289536, 4289538, 4289539, 4289540, 4289541, 4289542, 4289545, 4289546, 4289547, 4289589, 4289590, 4289591, 4293871, 4293872, 4293873, 4293874, 4293875, 4293876, 4293877, 4293878, 4293879, 4293880, 4293881, 4293882, 4293884, 4293885, 4293886, 4293887, 4293893, 4293894, 4293895, 4293896, 4293897, 4293899, 4293900, 4293904, 4294819, 4294820, 4294821, 4294822, 4294824, 4294825, 4294831, 4294832, 4294833, 4294835, 4294836, 4294838, 4294844, 4294845, 4294846, 4294847, 4294848, 4294849, 4294850, 4294851, 4294853, 4294854, 4294855, 4294856, 4294857, 4294858, 4294859, 4294860, 4294861, 4294862, 4294863, 4294864, 4294865, 4294866, 4294867, 4294868, 4294869, 4294876, 4294877, 4294878, 4294879, 4294880, 4294881, 4294882, 4294883, 4294884, 4294885, 4294887, 4294888, 4294889, 4294890, 4294891, 4294930, 4294931, 4294932, 4294933, 4294934, 4294937, 4294938, 4294939, 4294943, 4294944, 4294948, 4294949, 4294950, 4294951, 4294952, 4294953, 4294963, 4294964, 4294965, 4294966, 4294967, 4294970, 4294971, 4294975, 4294977, 4294978, 4294979, 4294980, 4294981, 4294982, 4294983, 4294985, 4294986, 4294987, 4294989, 4294990, 4294991, 4294992, 4294993, 4294997, 4294999, 4295001, 4295002, 4295003, 4295004, 4295005, 4295006, 4295007, 4295008, 4295009, 4295010, 4295011, 4295012, 4295013, 4295014, 4295015, 4295016, 4295017, 4295018, 4295520, 4295521, 4295523, 4295524, 4295525, 4295527, 4295530, 4295531, 4295532, 4295533, 4295534, 4295543, 4295544, 4295550, 4295556, 4295557, 4295558, 4295562, 4295565, 4295566, 4295567, 4295568, 4295569, 4295570, 4295571, 4295572, 4295573, 4295574, 4295575, 4295581, 4295582, 4295608, 4295609, 4295610, 4295611, 4295615, 4295616, 4295617, 4295618, 4295636, 4295649, 4295650, 4295651, 4295652, 4295653, 4295654, 4295655, 4295656, 4295657, 4295658, 4295659, 4295660, 4295661, 4295662, 4295663, 4295664, 4295665, 4295666, 4295667, 4295668, 4295669, 4295670, 4295671, 4295672, 4295673, 4295674, 4295675, 4295676, 4295677, 4295678, 4295679, 4295680, 4295681, 4295682, 4295683, 4295684, 4295685, 4295686, 4295687, 4295688, 4295689, 4295690, 4295691, 4295692, 4295693, 4295694, 4295695, 4295696, 4295697, 4295698, 4295699, 4295700, 4295701, 4295702, 4295703, 4295704, 4295747, 4295748, 4295750, 4295754, 4295755, 4295756, 4295758, 4295759, 4295768, 4295769, 4295777, 4295778, 4295779, 4295780, 4295781, 4295782, 4295783, 4295784, 4295785, 4295786, 4295787, 4295800, 4295801, 4295802, 4295803, 4295804, 4295805, 4295806, 4295807, 4295808, 4295809, 4295810, 4295811, 4295812, 4295813, 4295814, 4295815, 4295816, 4295817, 4295820, 4295821, 4295823, 4295824, 4295825, 4295826, 4295827, 4295828, 4295831, 4295833, 4295834, 4295835, 4295836, 4295837, 4295838, 4295839, 4295840, 4295841, 4295842, 4295868, 4295869, 4295870, 4295871, 4295872, 4295873, 4295874, 4295875, 4295876, 4295877, 4295878, 4295879, 4295880, 4295881, 4295882, 4295883, 4295884, 4295885, 4295886, 4295887, 4295888, 4295915, 4295936, 4295955, 4295956, 4295965, 4295966, 4295967, 4295968, 4295970, 4295972, 4295973, 4295974, 4295975, 4295976, 4295977, 4295978, 4295979, 4295980, 4295981, 4295982, 4295983, 4295984, 4295985, 4295986, 4295987, 4295988, 4295989, 4295990, 4295991, 4295992, 4295993, 4295994, 4295995, 4295996, 4295997, 4295998, 4295999, 4296000, 4296002, 4296003, 4296004, 4296005, 4296008, 4296009, 4296010, 4296012, 4296013, 4296014, 4296015, 4296016, 4296017, 4296018, 4297019, 4297020, 4297021, 4297022, 4297023, 4297024, 4297027, 4297028, 4297029, 4297030, 4297031, 4297032, 4297033, 4297034, 4297035, 4297036, 4297038, 4297040, 4297041, 4297042, 4297043, 4297044, 4297045, 4297046, 4297047, 4297048, 4297049, 4297050, 4297051, 4297052, 4297053, 4297055, 4297056, 4297057, 4297059, 4297093, 4297097, 4297102, 4297103, 4297105, 4297106, 4297107, 4297109, 4297110, 4297111, 4297112, 4297113, 4297114, 4297115, 4297116, 4297117, 4297118, 4297119, 4297120, 4297121, 4297122, 4297123, 4297125, 4297126, 4297127, 4297128, 4297129, 4297130, 4297131, 4297133, 4297134, 4297135, 4297136, 4297137, 4297138, 4297139, 4297140, 4297141, 4297142, 4297143, 4297149, 4297150, 4297151, 4297169, 4297170, 4297171, 4297172, 4297173, 4297174, 4297175, 4297176, 4297177, 4297190, 4297191, 4297192, 4297215, 4297216, 4297217, 4297218, 4297219, 4297221, 4297222, 4297223, 4297224, 4297225, 4297226, 4297227, 4297228, 4297229, 4297230, 4297231, 4297233, 4297251, 4297252, 4297253, 4297255, 4297256, 4297258, 4297259, 4297260, 4297261, 4297262, 4297264, 4297265, 4297291, 4297292, 4297293, 4297294, 4297295, 4297296, 4297297, 4297298, 4297299, 4297300, 4297301, 4297302, 4297303, 4297304, 4297305, 4297306, 4297307, 4297308, 4297309, 4297310, 4297311, 4297312, 4297313, 4297314, 4297316, 4297317, 4297319, 4297320, 4297321, 4297322, 4297323, 4297324, 4297325, 4297326, 4297327, 4297328, 4297329, 4297330, 4297331, 4297332, 4297333, 4297334, 4297335, 4297336, 4297337, 4297338, 4297339, 4297340, 4297341, 4297342, 4297343, 4297344, 4297346, 4297347, 4297348, 4297349, 4297350, 4297351, 4297352, 4297353, 4297354, 4297355, 4297356, 4297357, 4297359, 4297360, 4297362, 4297363, 4297364, 4297365, 4297366, 4297367, 4297368, 4297369, 4297371, 4297372, 4297374, 4297375, 4297376, 4297377, 4297378, 4297379, 4297380, 4297381, 4297382, 4297383, 4297384, 4297387, 4297388, 4297389, 4297390, 4297391, 4297392, 4297393, 4297394, 4297395, 4297396, 4297397, 4297398, 4297399, 4297404, 4297405, 4297408, 4297515, 4297516, 4297517, 4300368, 4300369, 4300370, 4300371, 4300372, 4300373, 4300374, 4300375, 4300380, 4300381, 4300382, 4300384, 4300385, 4300386, 4300387, 4300388, 4300389, AND 4300723.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
  • Product Description
    Powerheart 9390E 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). || Brand name: Cardiac Science. || Product name: Powerheart. || Device Operation: Semi-automatic. || Color: Yellow. || Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) || CPR Metronome: Yes. || Rescue Ready Indicator: Yes. || Text Display: Yes. || ECG Display: No.
  • Manufacturer
    Cardiac Science Corporation
  • 1 Event

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA

11 devices with a similar name

Learn more about the data here

Device Recall Powerheart AED G3
  • Model / Serial
    Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Throughout the United States, Canada and Europe.
  • Product Description
    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Model / Serial
    Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Throughout the United States, Canada and Europe.
  • Product Description
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Model / Serial
    Model no. 9300P serial numbers: 900290 thru 900870
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Throughout the United States, Canada and Europe.
  • Product Description
    Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Model / Serial
    serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore.
  • Product Description
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science Corporation
Device Recall Powerheart AED, G2
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.
  • Product Description
    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. || The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. || The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
  • Manufacturer
    Cardiac Science Corporation
6 more