Device Recall Powerheart AED, G2

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
  • Source
    USFDA