Device Recall Powerheart AED, G2

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.
  • Descripción del producto
    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. || The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. || The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
  • Manufacturer
  • 1 Event


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