Device Recall LIFEPAK 12

제조사

  • 제조사 주소
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • 제품 설명
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Each unit is given a unique serial number. All LIFEPAK 12 units are affected.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including government/military accounts.
  • 제품 설명
    LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 34087619, 34087620, 34087605, 34087610, 34087612, 34087035, 34087892, 34087602, 34087615, 34087616, 34087617, 34087618, 34086700, 34086709, 34086715, 34087613, 34086714, 34087609, 34087607, 34087614, 34087608, 34086718, 34086706, 34086719, 34086711, 34086713, 34086705, 34086717, 34086702, 34087606, 34086703, 34087033, 34086708, 34086712, 34087603, 34086707, 34087604, 34086716, 34087601, 34087034, 34091720, 33949930, 34091120, 34039430, 34039429, 34015786, 34011974, 33982989, 33899585, 33995356, 33995351, 33995350, 33995346, 33995360, 33995355, 33995369, 33995349, 33995348, 33995352, 33995347, 33995359, 33995353, 33995345, 33995358, 33995354, 12737672, 33913878, 34094631, 34049603, 34049601, 34049604, 34049611, 34049606, 34049607, 34049609, 34049612, 34049608, 34049610, 34049605, 34049602, 30859396, 33978921, 33978922, 33978923, 33978924, 34039468, 34039433, 34039470, 34083705, 34096379, 33915357, 33988150, 33992032, 33931367, 33931365, 33931364, 33931363, 33931362, 33931366, 34052702, 34052703, 33795379, 34095303, 34095298, 34095299, 34095304, 34095300, 34096375, 34095314, 34095313, 34095312, 34095307, 34095306, 34095305, 33862271, 34019587, 34020177, 34019586, 34019585, 34090338, 34090337, 34049130, 34043663, 34086675, 34086676, 34086671, 34086672, 34086674, 34086673, 33832318, 33888386, 33888372, 33888377, 33888376, 33888378, 33888379, 33888383, 33888385, 33888384, 33888373, 34044798, 34064654, 34019555, 34019554, 33802295, 33990042, 33982418, 33982417, 34074060, 34074061, 34095296, 34039463, 33950592, 33983052, 34099021, 34095323, 34082638, 34078647, 34078648, 34078646, 34082590, 34082591, 34048199, 34048200, 34049140, 34049141, 34048196, 34048198, 34045124, 34048194, 34010325, 33899587, 34096386, 34074089, 33974887, 33974888, 34078076, 34100491, 34100492, 34099179, 34099180, 34099178, 34099177, 34099176, 34090571, 34067899, 33995913, 33995914, 33974374, 33974373, 34013030, 34083205, 34019584, 10732394, 10732404, 34079488, 34084291, 34084290, 34004900, 34019558, 34019561, 33913867, 33913879, 33913888, 33995281, 33995280, 34090554, 34090556, 34090555, 34052280, 33991462, 34065273, 34048197, 34048195, 34034132, 34004904, 34082921, 34060126, 34060127, 34060128, 34086704, 34086701, 34086710, 33992506, 34074081, 34074073, 33855207, 33995302, 33995301, 34054626, 34054625, 33904163, 12776983, 33997196, 33987972, 33987973, 33928602, 34010320, 33974366, 34095302, 33938189, 34040207, 34039481, 34060174, 34060158, 34060161, 34060160, 34064667, 34003616, 34039469, 34060746, 34034134, 34106173, 33995035, 34074053, 34010323, 34090366, 34087611, 34090303, 34090302, 34091128, 34091129, 34095293, 33897593, 34078783, 34078784, 34078785, 34074072, 33992007, 33992020, 33993956, 33992022, 33992002, 33992021, 33992024, 33992025, 33992026, 33992004, 33992009, 33992015, 33992001, 33990248, 33992006, 33992005, 33992008, 33992014, 33992018, 33992017, 33990243, 33990246, 33990247, 33992011, 33992012, 33992013, 33992019, 33992010, 34019904, 33899702, 33960797, 33960796, 33960799, 33960798, 33960795, 33995049, 34061036, 34090589, 33931359, 33931358, 33931355, 33931356, 33931357, 34079490, 34079489, 34079833, 34079492, 34079491, 34079487, 34079486, 34079485, 33936114, 34068040, 34068041, 34078675, 33925842, 33925844, 33925846, 33925841, 33925843, 33925845, 33935283, 33935282, 33935281, 33935280, 33928109, 34090546, 34039464, 34082588, 33911101, 33911100, 33965863, 34074054, 34070493, 33997671, 33997672, 34078070, 34064659, 33996557, 33996553, 33996551, 33996550, 33996556, 33996549, 33996849, 33996558, 33996554, 33996552, 33993444, 34095321, 34095327, 34095331, 34095330, 34095326, 34095329, 34095320, 34095324, 34095328, 34095322, 33983339, 33976090, 33983346, 33983345, 33983338, 33983337, 33983336, 33983335, 32525390, 33995263, 34020191, 34019826, 34019557, 34019827, 34019556, 13583628, 34005592, 34005591, 34005587, 34005588, 34005589, 34005590, 33969580, 33969582, 33969581, 33969583, 33969584, 33995222, 34045762, 34099186, 34099185, 33991446, 33903858, 33997197, 34084471, 34075613, 34075614.    International Serial Numbers: 34098600, 34098601, 34090290, 34049509, 34049514, 34049515, 34083701, 34083702, 34044802, 33982442, 33982438, 33982439, 33934527, 33903205, 33903206, 33903208, 33903204, 33903198, 33903203, 33903207, 33903201, 33903210, 33903202, 33903199, 33903200, 33934528, 33934531, 33934529, 33934526, 33934530, 33928168, 33903217, 33928174, 33928165, 33982454, 33982437, 33982443, 33982440, 33903216, 33903215, 33982453, 33982452, 33982451, 33982450, 33982441, 33982448, 33982447, 33982446, 33982445, 33982444, 33982449, 33903209, 33928169, 33928160, 33928161, 33928162, 33928164, 33928170, 33928171, 33928172, 33928173, 33928175, 33928176, 33928177, 33928167, 33903211, 33903212, 33903213, 33903214, 33928159, 33950039, 33950038, 33950048, 33952773, 33952774, 33952775, 33952771, 34105152, 33950032, 33876945, 33876930, 33821315, 33876931, 34078216, 33876941, 33876943, 33876942, 33876938, 33876944, 33876952, 33876928, 33876946, 33876951, 33876950, 33876948, 33876940, 33876933, 33876935, 33876936, 33876937, 33950037, 33929937, 33950034, 33950043, 33950042, 33950041, 33950040, 33950053, 33950052, 33950051, 33950049, 33950045, 33950046, 33950047, 33950035, 33950050, 33950054, 33876949, 33876947, 33876939, 33876934, 33876932, 34079098, 33876929, 33950044, 33950033, 33950031, 33950030, 33950036, 34078082, 34078078, 34078081, 34078080, 34079097, 34083393, 34078079, 33985301, 33985300, 33985299, 33985307, 33986568, 33952772, 34079096, 34078215, 34078217, 34078225, 33982471, 33985298, 33985303, 33985304, 33986537, 33985302, 34009595, 34009594, 34009593, 34083729, 34083732, 34077752, 34106204, 34091376, 13669402, 33928605, 33985022, 33983183, 33979582, 33979583, 33974289, 33974293, 33952829, 33952830, 33798619, 33913915, 33798616, 33913909, 33918168, 33918735, 33918736, 33872713, 33918165, 33918166, 33918167, 33918181, 33795390, 33798614, 33896029, 33887441, 33798612, 33795399, 33795397, 33932561, 34094348, 34094349, 34091746, 33986283, 34039425, 33986294, 33983009, 33795389, 33983184, 33983178, 33983010, 33961531, 34074827, 34087714, 33974286, 34049521, 34049526, 34049527, 34049528, 34049529, 34049530, 34053704, 34049523, 33913897, 33913904, 34008743, 34008737, 34003664, 34003634, 34020680, 34020681, 34020164, 34020510, 34034118, 34034725, 33983556, 33974288, 33974287, 33979581, 33974290, 33974291, 34049522, 33983555, 33983554, 33979580, 33974229, 33974292, 33986320, 33913913, 34049520, 33986261, 33974295, 34053733, 34049525, 34053699, 34049524, 33913899, 33913900, 33913901, 33913902, 33985306, 33913905, 34069183, 33985305, 33913898, 33913903, 33913906, 33986313, 33986285, 34003817, 34049519, 34003650, 34003796, 34004911, 34008686, 34008744, 34008742, 34008740, 34008739, 34008738, 34008687, 34008745, 34008741, 34003658, 34020516, 34084458, 34084468, 34074427, 34084092, 34087711, 34087496, 33937399, 33937400, 33937398, 34090742, 33937401, 33937404, 34074835, 33937402, 34083715, 33937403, 33937397, 34090743, 33937405, 33910410, 33910411, 34090741, 34083714, 34044811, 34044812, 34039416, 34074102, 33979590, 34074107, 33983550, 34039419, 34073371, 34039413, 33958404, 33958774, 34074106, 33855054, 33921591, 33921592, 33880013, 33880012, 33880011, 33895654, 33900603, 33899646, 33895655, 33961098, 33961097, 33978886, 34074101, 34106223, 33973952, 33978885, 33979004, 33978888, 33978887, 33983551, 34039415, 34039409, 34039408, 33979564, 33979567, 34079036, 33895653, 33895652, 33895651, 33895650, 33895649, 33893664, 33892562, 33945926, 34074108, 34064246, 34039418, 33895656, 34064247, 34074105, 33968953, 34074099, 34074595, 34074596, 34074104, 34074098, 33949217, 33968972, 33969016, 34074103, 34008392, 34039421, 34012451, 34039422, 34040777, 34040525, 33969015, 34039406, 33968973, 34039405, 33968970, 33968962, 33968966, 33968964, 33969014, 34039407, 33968968, 34034122, 34034124, 34034127, 34034129, 34073370, 33983559, 34073365, 34073366, 34073376, 34065724, 34073364, 33905086, 33905087, 33905088, 33905089, 34003929, 34073369, 34073372, 34073373, 34073374, 34073375, 33968961, 33968963, 33983561, 34079035, 34043644, 34079040, 34079039, 34079037, 34073368, 34073367, 34073363, 34079038, 33928097, 34039410, 34043602, 33983560, 34039411, 34039412, 34043601, 34039414, 33928392, 33968957, 33968956, 33968955, 33968954, 34004876, 34043599, 34044807, 34004928, 34004927, 33968971, 34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
  • 제품 설명
    LIFEPAK 12 defibrillator/monitor
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number: LP12, VLP12-02-(various dash numbers).  Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 37126334, 37126335, 37126336, 37126342, 37126369, 37128467, 37128482, 37128485, 37128642, 37128643, 37128644, 37128646, 37128651, 37128652, 37128653, 37128660, 37128661, 37128662, 37128663, 37128666, 37128667, 37128668, 37128669, 37128670, 37128674, 37128678, 37135341, 37135394, 37135396, 37135397, 37135398, 37135418, 37135423, 37135424, 37135425, 37136603, 37136622, 37136623, 37136670, 37138749, 37138751, 37138756, 37138759, 37138769, 37138777, 37139181, 37139182, 37139183, 37139184, 37139186, 37139187, 37139188, 37139189, 37139190, 37139191, 37139192, 37139193, 37139194, 37139202, 37139203, 37139204, 37139205, 37139206, 37139207, 37139252, 37139254, 37139315, 37139317, 37139318, 37139324, 37139932, 37139933, 37140146, 37140147, 37143216, 37143418, 37143420, 37143457, 37143531, 37143636, 37146769, 37148809, 37148812, 37148863, 37148863, 37148864, 37148864, 37148865, 37148865, 37148867, 37148868, 37148868, 37148872, 37148878, 37148881, 37148881, 37148882, 37148882, 37154928, 37154936, 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37652880, 37652883, 37652883, 37660898, 37660902, and 37661630.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
  • 제품 설명
    Biphasic LIFEPAK 12 defibrillator / monitor.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries: ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.
  • 제품 설명
    The LIFEPAK12 Defibrillator/Monitor. || The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.
  • Manufacturer