Rappel de Powerheart, CardioVive, Nihon Kohden and/or Responder AED

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cardiac Science Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53608
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1424-2010
  • Date de mise en oeuvre de l'événement
    2009-10-12
  • Date de publication de l'événement
    2010-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
  • Source
    USFDA