Devices

Device Recall HeartStart MRx Monitor/Defribillator

  • 모델명 / 제조번호(시리얼번호)
    US00100253, US00547494, US00565643, US00567331, US00100950, US00558361, US00565651, US00567332, US00204282, US00560173, US00565652, US00567333, US00210992, US00560174,US00565653, US00567334, US00210993, US00560175, US00565655, US00567335, US00210994, US00560176, US00565656, US00567336, US00210995, US00560177, US00565657, US00567337, US00210996, US00560178, US00565658, US00567338, US00210997, US00561068, US00565660, US00567339, US00210998, US00561724, US00565661, US00567340,  US00210999, US00563602, US00565662, US00567341, US00211000, US00563603, US00565663, US00567720, US00211001, US00563606, US00565664, US00567721, US00212264, US00563607, US00565665, US00567722, US00212265, US00565069, US00565666, US00567723,  US00212266, US00565414, US00566434, US00567724, US00212267, US00565415, US00566564, US00568419, US00212268, US00565416, US00567302, US00568656, US00322574, US00565417, US00567303, US00568703, US00322575, US00565418, US00567304, US00568704 US00322876, US00565419, US00567305, US00568705, US00322877, US00565420, US00567306, US00568706, US00323134, US00565421, US00567307, US00568748, US00323135, US00565422, US00567308, US00568749, US00323137, US00565423, US00567309, US00568750,  US00323138, US00565424, US00567310, US00568751, US00541205, US00565425, US00567311, US00568752, US00541250, US00565427, US00567312, US00568753, US00541254, US00565428, US00567313, US00568754, US00541364, US00565429, US00567314, US00568755,  US00541370, US00565430, US00567315, US00568756, US00541397, US00565446, US00567316, US00568757, US00541402, US00565447, US00567317, US00568758, US00541403, US00565448, US00567318, US00568759, US00541405, US00565449, US00567319, US00568760,  US00543683, US00565450, US00567320, US00568761, US00543684, US00565451, US00567321, US00568762, US00543860, US00565452, US00567322, US00568763, US00544078, US00565453, US00567323, US00568764, US00544082, US00565454, US00567324, US00568765,  US00544089, US00565455, US00567325, US00568766, US00544095, US00565456, US00567326, US00568767, US00547383, US00565457, US00567327, US00568768, US00547456, US00565458, US00567328, US00568769, US00547457, US00565459, US00567329, US00568770, US00547458, US00565642, US00567330, US00568771
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain.
  • 제품 설명
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Medical Systems, Inc.
  • 1 Event

제조사

Philips Medical Systems, Inc.
  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall HeartStart MRx Monitor/Defribillator
  • 모델명 / 제조번호(시리얼번호)
    Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Canada, AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and YEMEN.
  • 제품 설명
    HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Medical Systems, Inc.