Events

Recall of Device Recall Powerheart AED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54517
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-2010
  • Event Initiated Date
    2010-02-03
  • Event Date Posted
    2010-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88620
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    A component of the aed device may fail during a rescue attempt and the aed will not be able to deliver therapy.
  • Action
    The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).

Device

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

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