Recall of Powerheart, CardioVive, Nihon Kohden and/or Responder 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
    53608
  • Event Risk Class
    Class 1
  • Event Number
    Z-1424-2010
  • Event Initiated Date
    2009-10-12
  • Event Date Posted
    2010-04-27
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-02-13
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Certain models of powerheart g3 aeds may not have received adequate electrical safety testing prior to being shipped from the factory. affected models are: powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, cardiovive 92532, 92533, nk 9200g, 9231, and responder 2019198 and 2023440. the affected devices were manufactured between october 29, 2003 and february 10, 2009.
  • Action
    Cardiac Science issued "Urgent - Medical Device Corrective Action" notices dated October 2009. Customers were instructed to identify the affected product and arrange for product replacement with the firm. Where possible, end user information was requested for further follow-up by the firm. For further information, contact Cardiac Science at 1-877-402-4599 or by email at AED155@cardiacscience. com.

Device

  • Model / Serial
    Serial Numbers: 331104, 331604, 337397, 337878, 339693, 340376, 341871, 342086, 344846, 345416, 345909, 346118, 352290, 355192, 358479, 361455, 361573, 362241, 363055, 363268, 363491, 363662, 364586, 370323, 371556, 378795, 387103, 390455, 902084, 4001786, 4002442, 4006599, 4006773, 4008380, 4009395, 4017448, 4029897, 4030020, 4031719, 4035141, 4037678, 4038609, 4038631, 4039224, 4039431, 4039467, 4039645, 4039672, 4039807, 4040185, 4040577, 4040749, 4040833, 4041493, 4041535, 4041684, 4042176, 4042279, 4042808, 4043020, 4043292, 4044056, 4044528, 4044602, 4044862, 4045071, 4045087, 4045252, 4045536, 4045614, 4046271, 4046456, 4046647, 4047057, 4047176, 4047282, 4047283, 4047743, 4048352, 4048662, 4048730, 4048741, 4048941, 4100095, 4101486, 4102240, 4102554, 4102687, 4102872, 4103794, 4104098, 4104101, 4104118, 4104164, 4104492, 4104507, 4104622, 4104660, 4104970, 4105065, 4105091, 4105230, 4105549, 4105836, 4106271, 4106382, 4106588, 4106694, 4106729, 4107001, 4107262, 4107491, 4108137, 4108340, 4108588, 4109950, 4110109, 4110236, 4111511, 4111991, 4112442, 4112495, 4112645, 4112739, 4113014, 4113356, 4114235, 4114254, 4114391, 4115645, 4115737, 4115780, 4116034, 4116111, 4116290, 4116464, 4116510, 4116572, 4116580, 4116759, 4117241, 4117508, 4117647, 4117648, 4117688, 4117731, 4117762, 4117783, 4117803, 4117811, 4117825, 4117827, 4117833, 4117835, 4117841, 4117863, 4117872, 4117878, 4117882, 4117902, 4117903, 4117907, 4117937, 4117942, 4118131, 4118157, 4118166, 4118190, 4118195, 4118200, 4118202, 4118207, 4118219, 4118220, 4118338, 4118386, 4118667, 4118686, 4118744, 4118838, 4119048, 4119205, 4119626, 4119674, 4119693, 4119750, 4119815, 4120151, 4120221, 4120537, 4120558, 4121192, 4121694, 4121820, 4121952, 4122114, 4122329, 4122393, 4122425, 4122918, 4123358, 4123713, 4124299, 4124350, 4124802, 4124912, 4125167, 4125423, 4125462, 4125557, 4125631, 4126032, 4126087, 4126252, 4126451, 4126521, 4126548, 4126560, 4126912, 4127605, 4127886, 4128007, 4128008, 4128086, 4128099, 4128554, 4129007, 4129247, 4129312, 4130097, 4130310, 4131363, 4132227, 4132369, 4132695, 4132791, 4132917, 4133051, 4133397, 4133626, 4133808, 4133813, 4134207, 4134315, 4134736, 4134903, 4135035, 4135106, 4135730, 4135758, 4136171, 4136374, 4136415, 4136691, 4136773, 4136776, 4136797, 4137336, 4137354, 4137358, 4137729, 4138206, 4138251, 4138360, 4138582, 4139405, 4139414, 4139564, 4139679, 4139692, 4139793, 4139824, 4139941, 4139980, 4140041, 4140292, 4140351, 4140382, 4140595, 4140664, 4140813, 4140887, 4141019, 4141269, 4141427, 4141980, 4142050, 4142136, 4142478, 4142698, 4142717, 4142847, 4143332, 4143404, 4143594, 4143904, 4144060, 4144255, 4145277, 4145465, 4145470, 4145474, 4145479, 4145481, 4145484, 4145486, 4145490, 4145494, 4145495, 4145497, 4145511, 4146200, 4146250, 4146638, 4146860, 4147196, 4147402, 4147486, 4147612, 4147857, 4148022, 4148297, 4148310, 4148945, 4148976, 4149089, 4149466, 4149467, 4149468, 4149469, 4149470, 4149472, 4149481, 4149482, 4149483, 4149485, 4149486, 4149487, 4149488, 4149489, 4149490, 4149492, 4149493, 4149494, 4149495, 4149496, 4149497, 4149499, 4149500, 4149502, 4149503, 4149504, 4149505, 4149506, 4149507, 4149508, 4149509, 4149510, 4149511, 4149512, 4149685, 4150723, 4150808, 4150810, 4150813, 4150890, 4150954, 4151034, 4151047, 4151057, 4151064, 4151082, 4151083, 4151085, 4151087, 4151110, 4151119, 4151121, 4151124, 4151130, 4151131, 4151132, 4151134, 4151135, 4151136, 4151137, 4151139, 4151140, 4151141, 4151143, 4151156, 4151157, 4151158, 4151159, 4151161, 4151162, 4151165, 4151166, 4151167, 4151169, 4151170, 4151172, 4151174, 4151175, 4151178, 4151180, 4151182, 4151188, 4151191, 4151192, 4151195, 4151197, 4151198, 4151202, 4151204, 4151205, 4151206, 4151207, 4151210, 4151211, 4151212, 4151568, 4151572, 4151573, 4151583, 4151591, 4151593, 4151607, 4151614, 4151617, 4151621, 4151625, 4151627, 4151628, 4151630, 4151646, 4151649, 4151653, 4151663, 4151672, 4151698, 4151700, 4151707, 4151784, 4151880, 4152063, 4152084, 4152259, 4152324, 4152359, 4152364, 4152396, 4152399, 4152413, 4152429, 4152436, 4152442, 4152443, 4152445, 4152450, 4152458, 4152463, 4152471, 4152478, 4152504, 4152517, 4152529, 4152538, 4152540, 4152546, 4152562, 4152564, 4152580, 4152599, 4152601, 4152606, 4152614, 4152639, 4152649, 4152658, 4152667, 4152668, 4152672, 4152681, 4152686, 4152696, 4152715, 4152720, 4152725, 4152737, 4152739, 4152749, 4152768, 4152773, 4152778, 4152785, 4152786, 4152799, 4152802, 4152803, 4152819, 4152838, 4152842, 4152847, 4152860, 4152867, 4152871, 4152879, 4152880, 4152883, 4152888, 4152925, 4152938, 4152943, 4152960, 4152962, 4152972, 4152979, 4152980, 4152984, 4152988, 4152996, 4153005, 4153010, 4153024, 4153025, 4153031, 4153033, 4153036, 4153038, 4153041, 4153052, 4153064, 4153067, 4153107, 4153115, 4153165, 4153174, 4153175, 4153178, 4153188, 4153206, 4153235, 4153240, 4153241, 4153259, 4153271, 4153276, 4153294, 4153296, 4153297, 4153325, 4153329, 4153376, 4153379, 4153390, 4153408, 4153418, 4153441, 4153446, 4153457, 4153683, 4154225, 4154227, 4154243, 4154245, 4154273, 4154274, 4154275, 4154288, 4154295, 4154527, 4154719, 4155671, 4155836, 4155984, 4156038, 4156255, 4156600, 4156601, 4156602, 4156603, 4156604, 4156605, 4156606, 4156608, 4156610, 4156611, 4156624, 4156627, 4156653, 4156711, 4156730, 4156732, 4156733, 4156734, 4156736, 4156740, 4156741, 4156745, 4156746, 4156748, 4156749, 4156752, 4156753, 4156754, 4156756, 4156759, 4156761, 4156764, 4156767, 4156768, 4156773, 4156775, 4156777, 4156845, 4156848, 4156948, 4156978, 4157103, 4157193, 4157520, 4157544, 4157618, 4157731, 4158108, 4158124, 4158540, 4158819, 4158832, 4158836, 4159085, 4159689, 4159720, 4159849, 4160002, 4160111, 4160127, 4160193, 4160236, 4160357, 4160494, 4160620, 4160635, 4160686, 4160803, 4160836, 4161085, 4161214, 4161301, 4161539, 4161644, 4161646, 4161692, 4161880, 4162344, 4162348, 4162693, 4162700, 4162809, 4162893, 4162997, 4163385, 4163423, 4163507, 4163592, 4163829, 4163883, 4164016, 4164055, 4164366, 4164549, 4164642, 4164686, 4164784, 4164836, 4164854, 4165042, 4165123, 4165358, 4165434, 4165577, 4165977, 4165978, 4166023, 4166087, 4166256, 4166505, 4166598, 4166758, 4167154, 4167281, 4167544, 4167676, 4167956, 4168017, 4168291, 4168724, 4168862, 4168989, 4169027, 4169259, 4169364, 4169399, 4169623, 4170042, 4170243, 4170254, 4170421, 4170992, 4171241, 4171347, 4171765, 4171900, 4172087, 4172313, 4172451, 4172543, 4172695, 4173060, 4173160, 4173425, 4173466, 4173666, 4173734, 4174096, 4174150, 4174151, 4174383, 4174540, 4174665, 4175183, 4175416, 4175471, 4175701, 4175759, 4175969, 4176459, 4176549, 4176605, 4177368, 4177464, 4177624, 4177716, 4178343, 4178530, 4178644, 4178745, 4179001, 4179081, 4179432, 4179599, 4180156, 4180194, 4180592, 4180744, 4180930, 4181030, 4181045, 4181648, 4182097, 4182344, 4182550, 4182818, 4182892, 4182986, 4183077, 4183220, 4183635, 4183880, 4184019, 4184072, 4184120, 4184185, 4184273, 4184530, 4184620, 4184932, 4185007, 4185021, 4185204, 4186135, 4186565, 4186914, 4187049, 4187425, 4187429, 4187442, 4187456, 4187505, 4187528, 4187699, 4187823, 4187862, 4188125, 4188285, 4188348, 4188396, 4188550, 4188929, 4189057, 4189408, 4189417, 4189423, 4189872, 4189940, 4190140, 4190185, 4190222, 4190348, 4190743, 4190784, 4191191, 4191485, 4191805, 4191927, 4192037, 4192125, 4192270, 4192605, 4192665, 4192708, 4192754, 4193111, 4193204, 4193306, 4193951, 4193975, 4194236, 4194389, 4194403, 4194409, 4194422, 4194480, 4194993, 4195072, 4195100, 4195137, 4195348, 4195760, 4196115, 4196640, 4196734, 4197173, 4197390, 4197707, 4198049, 4198465, 4198497, 4198643, 4198796, 4198883, 4199702, 4199781, 4200226, 4200491, 4200501, 4200531, 4200671, 4200811, 4200823, 4200910, 4200911, 4201196, 4201278, 4201628, 4201855, 4201922, 4201983, 4202009, 4202083, 4202138, 4202517, 4202720, 4203084, 4203375, 4203777, 4203804, 4203846, 4204264, 4204368, 4204523, 4204589, 4204992, 4205228, 4205458, 4205479, 4205683, 4205796, 4205809, 4206165, 4206321, 4206486, 4206559, 4207016, 4207047, 4207127, 4207335, 4207903, 4207930, 4208070, 4208076, 4208318, 4208415, 4208552, 4208881, 4209024, 4209178, 4209366, 4209440, 4210123, 4210136, 4210315, 4210586, 4210625, 4210649, 4210761, 4210916, 4210953, 4210968, 4211043, 4211083, 4211281, 4211379, 4211508, 4211692, 4211712, 4211795, 4211832, 4211968, 4212149, 4212194, 4212391, 4212412, 4212886, 4212956, 4213501, 4213588, 4213700, 4213736, 4213743, 4213866, 4213901, 4213961, 4214229, 4214256, 4214552, 4214950, 4214976, 4215024, 4215031, 4215063, 4215297, 4215407, 4215416, 4215455, 4215599, 4215870, 4215961, 4216011, 4216284, 4216336, 4216371, 4216467, 4216503, 4216610, 4216671, 4216767, 4216841, 4216946, 4216980, 4217166, 4217217, 4217372, 4217505, 4217591, 4217625, 4217651, 4217652, 4217861, 4217904, 4217914, 4218050, 4218317, 4218318, 4218324, 4218331, 4218441, 4218629, 4218666, 4218932, 4218968, 4219107, 4219148, 4219155, 4219381, 4219954, 4220334, 4220423, 4220715, 4220743, 4221053, 4221202, 4221522, 4221644, 4221934, 4221996, 4222205, 4222411, 4222554, 4222581, 4222582, 4222681, 4222883, 4222950, 4222963, 4223039, 4223054, 4223107, 4223664, 4223848, 4224027, 4224121, 4224152, 4224686, 4225092, 4225353, 4225545, 4225622, 4226025, 4226061, 4226121, 4226256, 4226310, 4226324, 4226462, 4226652, 4226719, 4226895, 4227193, 4227213, 4227469, 4227526, 4227549, 4227660, 4227769, 4227823, 4227824, 4227863, 4227903, 4228076, 4228113, 4228391, 4228656, 4228830, 4228862, 4228875, 4228892, 4229027, 4229070, 4229208, 4229485, 4229512, 4229529, 4229589, 4229648, 4229820, 4229939, 4230005, 4230129, 4230770, 4230985, 4231016, 4231074, 4231217, 4231627, 4231728, 4231793, 4231810, 4231875, 4231918, 4232144, 4232345, 4232426, 4232464, 4232517, 4232538, 4232558, 4232670, 4232671, 4232806, 4232914, 4232944, 4233153, 4233607, 4234032, 4234432, 4234739, 4234787, 4234800, 4236149, 4236181, 4236259, 4236319, 4236567, 4236753, 4236759, 4236805, 4236883, 4237341, 4237486, 4237490, 4237582, 4237595, 4237672, 4237714, 4237859, 4237983, 4240118, 4240204, 4240544, 4240707, 4242546, 4242592, 4243602, 4243627, 4244211, 4244258, 4244262, 4244279, 4244303, 4244432, 4244538, 4244746, 4244817, 4245198, 4245301, 4245487, 4245607, 4246012, 4246013, 4246030, 4246096, 4246395, 4246529, 4246533, 4246573, 4246620, 4246896, 4247013, 4247029, 4247036, 4247205, 4247256, 4247399, 4247461, 4247607, 4247679, 4247681, 4247687, 4247933, 4248178, 4248570, 4248629, 4248996, 4249504, 4249511, 4249535, 4250443, 4250521, 4250550, 4250919, 4250937, 4250983, 4251443, 4252619, 4252668, 4253145, 4211109ppc, 4221006ppc, 4221940ppc, 4227360ppc, 4227446ppc, 4230124ppc, 4230260ppc, 4238396ppc, 4239157ppc, and 4243424ppc.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Distributed to the United States, Australia, Belgium, Canada, Chile, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Marshall Islands, Nigeria, Norway, Philippines, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.
  • Product Description
    Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Cardiac Science, Bothell, WA 98021. || Indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer

Manufacturer

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