Devices

Device Recall Powerheart 9390E automated external defibrillator

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 4259985, 4260065, 4260137, 4260148, 4260174, 4260179, 4260181, 4261110, 4261111, 4261112, 4261113, 4261114, 4261115, 4261116, 4261117, 4261118, 4261119, 4261120, 4261121, 4261122, 4261123, 4261125, 4261126, 4261127, 4261128, 4261129, 4261130, 4261131, 4261132, 4261133, 4261134, 4261136, 4261138, 4261139, 4261140, 4261141, 4261142, 4261143, 4261144, 4261145, 4261147, 4261149, 4261150, 4261151, 4261153, 4261154, 4261155, 4261156, 4261157, 4261158, 4261160, 4261161, 4261162, 4261163, 4261164, 4261166, 4261168, 4261169, 4261170, 4261172, 4261174, 4261175, 4261177, 4261178, 4261179, 4261180, 4261181, 4261182, 4261183, 4261184, 4261185, 4261186, 4261188, 4261189, 4261190, 4261216, 4261217, 4261284, 4261285, 4261292, 4261299, 4261300, 4261301, 4261305, 4261306, 4261308, 4261312, 4261313, 4261317, 4261319, 4261320, 4261321, 4261325, 4261326, 4261329, 4261330, 4261332, 4261333, 4261342, 4261343, 4261348, 4261351, 4261352, 4261355, 4261356, 4261358, 4261360, 4261361, 4261365, 4261370, 4261381, 4261382, 4261383, 4261384, 4261385, 4261386, 4261387, 4261388, 4261394, 4261395, 4261396, 4261397, 4261398, 4261399, 4261400, 4261401, 4261402, 4261403, 4261404, 4261405, 4261406, 4261407, 4261408, 4261409, 4261410, 4261411, 4261412, 4261413, 4261414, 4261415, 4261416, 4261417, 4261420, 4261422, 4261423, 4261425, 4261449, 4261450, 4261451, 4261463, 4261465, 4261473, 4261475, 4261476, 4261477, 4261478, 4261479, 4261480, 4261481, 4261482, 4261483, 4261484, 4261485, 4261486, 4261487, 4261488, 4261489, 4261490, 4261492, 4261495, 4261496, 4261498, 4261499, 4261500, 4261501, 4261502, 4261503, 4261505, 4261506, 4261507, 4261508, 4261512, 4261513, 4261514, 4261515, 4261516, 4261517, 4261518, 4261519, 4261520, 4261522, 4261523, 4261524, 4261526, 4261527, 4261528, 4261529, 4261530, 4261531, 4261532, 4261534, 4261535, 4261536, 4261537, 4261538, 4261539, 4261540, 4261541, 4261542, 4261543, 4261544, 4261545, 4261546, 4261547, 4261548, 4261549, 4261551, 4261552, 4261554, 4261555, 4261557, 4261558, 4261559, 4261560, 4261561, 4261562, 4261563, 4261564, 4261565, 4261566, 4261567, 4261568, 4261570, 4261571, 4261572, 4261573, 4261574, 4261575, 4261576, 4261577, 4261579, 4261580, 4261586, 4261587, 4261592, 4261597, 4261598, 4261605, 4261608, 4261610, 4261611, 4261613, 4261614, 4261615, 4261617, 4261618, 4261621, 4261623, 4261624, 4261626, 4261628, 4261630, 4261631, 4261632, 4261633, 4261634, 4261635, 4261636, 4261637, 4261638, 4261639, 4261640, 4261641, 4261642, 4261643, 4261644, 4261645, 4261646, 4261647, 4261648, 4261649, 4261650, 4261651, 4261652, 4261653, 4261654, 4261656, 4261657, 4261660, 4261662, 4261663, 4261664, 4261665, 4261666, 4261670, 4261672, 4261676, 4261678, 4261679, 4261680, 4261683, 4261688, 4261689, 4261690, 4261691, 4261692, 4261695, 4261696, 4261697, 4261700, 4261709, 4261711, 4261712, 4261713, 4261714, 4261716, 4261718, 4261721, 4261726, 4261727, 4261729, 4261733, 4261734, 4261737, 4261739, 4261744, 4261745, 4261746, 4261747, 4261748, 4261750, AND 4261751.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
  • 제품 설명
    Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
    Cardiac Science Corporation
  • 1 Event

제조사

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

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

데이터에 대해 더 자세히 알아보기 여기

Device Recall Powerheart 9390E automated external defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
  • 제품 설명
    Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
    Cardiac Science Corporation