Device Recall Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED

  • Modèle / numéro de série
    Serial numbers: 022805, 031605, 303024, 322627, 322644, 328877, 900034, 900055, 900061, 900110, and 972196. Serial numbers Ranges:  from 900134 through 903240;  from 329024 through 394573; from 400001 through 4049272;  from 4100002 through 4370573;  from 92532-0000501 through 92532-0001310; and from 92533-0000000 through 92533-0001340.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) This action applies only to domestic
  • Description du dispositif
    Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. || Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. || Brand names: Powerheart AED, G3, CardioVive AED, GE Responder || AED, Nihon Kohden CardioLife AED.
  • Manufacturer
  • 1 Event

Fabricant

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