Events

Rappel de Device Recall Power Heart

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, Inc..

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
    29024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1033-04
  • Date de mise en oeuvre de l'événement
    2004-05-24
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32992
  • 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
    Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
  • Action
    A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.

Device

Device Recall Power Heart
  • Modèle / numéro de série
    Serial Numbers of the recalled Model 9200 RD and Model 9210 RD AEDs are: 300122, 300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426, 306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through 308530, 308839, 309180, 309218, 309236, 309426, 309438, 309561, 309691 through 309894, 309897, 309903 through 309908, 309913, 309915, 309917, 309922, 309924, 309929, 309930, 309944, 309959, 309971 through 310170, 310181, 310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through 312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973, 317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278, 318171 ¿ 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435, 318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
  • Description du dispositif
    Power Heart AED Automatic External Defibrillator, Model 9200 RD
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • Adresse du fabricant
    Cardiac Science, Inc., 5474 Feltl Rd., Minneapolis MN 55343-7982
  • Source
    USFDA