Device Recall Cardiac Resynchronization Therapy Defrillator

  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS FOR MODEL #H170 :  361904, 363420, 363895, 364293, 364294, 364349, 364350, 364470, 364480, 364485, 364486, 364494, 364510, 364539, 364617 and 364621; and  SERIAL NUMBERS MODEL #H175:  312616, 312962, 312965, 312973, 313064, 315207, 315209, 315212, 315213, 315219, 315227, 315238, 315248, 315251, 315265, 315398, 315431, 315446, 316045, 316064 and 316123; and  SERIAL NUMBERS MODEL #H177:  281692, 282937, 284803, 284874, 284896, 285009, 285019, 285091, 285110, 285111, 285120, 285134 285332 and 285357; and  SERIAL NUMBERS MODEL #H179:  111439, 112977, 113822, 113910, 114275, 114375, 114394, 114488, 114503, 114506, 114515, 114523, 114652, 114680, 114682 and 114714; and  SERIAL NUMBERS MODEL #H190:  312166, 311764, 311803, 311894, 312164 and 312177; and  SERIAL NUMBERS MODEL #H195:  352084, 353252, 353389, 351230, 353157 and 353388; and  SERIAL NUMBERS MODEL #H197:  310113, 310253, 310651, 310335, 310337, 310339, 310342, 310357, 310361, 310442, 310464, 310465, 310518, 310660, 310691, 310696, 310814, 310933 and 311096; and  SERIAL NUMBERS MODEL #H199:  321405, 321060, 321415, 321423, 321478, 321489, 321494, 321498 and 321689; and  SERIAL NUMBERS MODEL #M177:  200050 and 200051; and  SERIAL NUMBERS MODEL #M179:  200098, 200099 and 200033.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
  • 제품 설명
    Guidant Contak¿ Renewal¿ 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA