Devices

Device Recall Powerheart 9390E automated external defibrillator

  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
  • Product Description
    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

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Powerheart 9390E automated external defibrillator
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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