Retiro De Equipo (Recall) de Powerheart, CardioVive, Nihon Kohden and/or Responder AED

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardiac Science Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    53608
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1424-2010
  • Fecha de inicio del evento
    2009-10-12
  • Fecha de publicación del evento
    2010-04-27
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-02-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    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.
  • Acción
    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

  • Modelo / 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, 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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.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

  • Dirección del fabricante
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA