Device Recall LIFEPAK 15 Monitor/Defibrillator

  • Modelo / Serial
    SERIAL NUMBERS:  42738872, 44554102, 42701550, 42702539, 42730815, 42800549, 42803986, 42862109, 42884428, 42944609, 42989327, 43022460, 43040692, 43048791, 43066974, 43116838, 43116994, 43119477, 43132954, 43133203, 43133221, 43133906, 43154308, 43154457, 43156695, 43161425, 43163930, 43164076, 43164158, 43166133, 43206034, 43210019, 43219622, 43226291, 43230032, 43232487, 43232904, 43247389, 43251050, 43253506, 43253916, 43254032, 43258901, 43293290, 43321556, 43388132, 43388137, 43388541, 43405542, 43407947, 43409346, 43429508, 43465372, 43472036, 43472591, 43480824, 43489606, 43492883, 43576021, 43616526, 43641893, 43691775, 43715563, 43735849, 43764249, 43800357, 43805213, 43825370, 43826635, 43843347, 43869096, 43884778, 43922984, 43938506, 43947198, 43962139, 43964195, 43968233, 43981293, 43999541, 44010117, 44010465, 44039473, 44056838, 44060132, 44072885, 44073149, 44090669, 44092118, 44094122, 44108545, 44112183, 44117966, 44150897, 44167052, 44168042, 44179750, 44199424, 44225054, 44225258, 44226227, 44226585, 44226654, 44231094, 44233618, 44234803, 44234840, 44237875, 44255648, 44262283, 44262826, 44264102, 44264573, 44265421, 44271391, 44283558, 44287000, 44289115, 44293297, 44303302, 44312782, 44315479, 44327764, 44342010, 44352664, 44372343, 44416667, 44435825, 44438567, 44439898, 44449825, 44450073, 44452220, 44458445, 44460124, 44460749, 44463853, 44466514, 44473363, 44483809, 44486872, 44487784, 44487992, 44488101, 44489681, 44492189, 44492223, 44492252, 44492760, 44492832, 44494129, 44496734, 44497169, 44497196, 44497761, 44497866, 44498576, 44500827, 44500943, 44501037, 44501047, 44501112, 44501201, 44501465, 44501806, 44501832, 44502009, 44502159, 44502179, 44502310, 44502686, 44502718, 44502776, 44502815, 44502943, 44503096, 44508212, 44508273, 44508330, 44508331, 44508358, 44508440, 44508498, 44508645, 44508868, 44509074, 44509520, 44509538, 44511211, 44511231, 44511273, 44511519, 44511573, 44512604, 44513321, 44513358, 44518244, 44518479, 44518497, 44518703, 44518786, 44518917, 44518981, 44519083, 44519095, 44519255, 44519301, 44519307, 44519381, 44519548, 44524967, 44525130, 44525416, 44527324, 44530479, 44530594, 44530719, 44530800, 44531488, 44531803, 44532088, 44534804, 44534900, 44534991, 44535111, 44535241, 44535452, 44535582, 44535643, 44536176, 44536780, 44536823, 44536897, 44538798, 44538819, 44539781, 44539880, 44541779, 44541917, 44548263, 44548530, 44548558, 44548749, 44548825, 44549064, 44549220, 44549413, 44549964, 44550150, 44550234, 44550467, 44550552, 44550575, 44550613, 44550642, 44550675, 44552029, 44552066, 44552865, 44553122, 44554175, 44554259, 44554351, 44554520, 44554837, 44554941, 44555058, 44555261, 44556688, 44557824, 44558175, 44558252, 44558385, 44559077, 44559369, 44559455, 44560001, 44560185, 44561655, 44561903, 44562074, 44562559, 44562662, 44562754, 44563762, 44564474, 44564491, 44571952, 44572025, 44572171, 44572228, 44572357, 44572374, 44572595, 44572865, 44573101, 44573148, 44573485, 44573956, 44574467, 44574766, 44574771, 44574821, 44574929, 44574939, 44575793, 44575871, 44575898, 44576359, 44576647, 44577004, 44577022, 44577116, 44577219, 44578054, 44578080, 44578192, 44578272, 44579036, 44579299, 44579496, 44579697, 44579713, 44579857, 44581304, 44581382, 44583260, 44583657, 44583701, 44584213, 44586462, 44587097, 44587099, 44587181, 44587302, 44587358, 44587899, and 44587976.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product part numbers: V15-2-000xxxxxx.  Serial Numbers: various, non-contiguous as follows:  Device Serial Numbers: 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 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38360336, 38361932, 38361933, 38361934, 38361935, 38361937, 38361938, 38361939, 38361939, 38361940, 38361941, 38361943, 38361943, 38361944, 38361945, 38361946, 38361947, 38361947, 38361987, 38361988, 38361989, 38361990, 38361991, 38362760, 38362760, 38362761, 38362762, 38362763, 38362765, 38362766, 38362767, 38362768, 38362769, 38362771, 38362854, 38362855, 38362856, 38362857, 38362858, 38362859, 38362860, 38362861, 38362862, 38362863, 38363399, 38363401, 38363403, 38363404, 38363405, 38363407, 38363412, 38363426, 38363448, 38363451, 38364965, 38364966, 38364967, 38364968, 38364969, 38364970, 38364971, 38364972, 38364973, 38364974, 38364975, 38364976, 38364977, 38364978, 38364979, 38364980, 38364981, 38364982, 38364983, 38364984, 38365243, 38365244, 38365245, 38365247, 38365248, 38365249, 38365254, 38365255, 38365256, 38365257, 38365567, 38365571, 38365573, 38365574, 38365576, 38365577, 38365578, 38365579, 38365580, 38365581, 38365763, 38365764, 38365765, 38365766, 38365767, 38365768, 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38370426.38370427, 38370428, 38370429, 38370430, 38370431, 38370432, 38370433, 38370434, 38370435, 38370435, 38370436, 38370437, 38370438, 38370439, 38370440, 38370441, 38370441, 38370442, 38371193, 38371195, 38371196, 38371197, 38371198, 38371199, 38371200, 38371200, 38371201, 38371202, 38371203, 38371205, 38371210, 38371211, 38371212, 38371213, 38371214, 38371215, 38371216, 38371218, 38371219, 38371700, 38371701, 38371702, 38371705, 38371706, 38371707, 38371708, 38371709, 38371710, 38371710, 38371711, 38371712, 38371713, 38371713, 38371714, 38371715, 38371717, 38371718, 38371718, 38371719, 38371720, 38371721, 38371722, 38372518, 38372518, 38372519, 38372520, 38372521, 38372522, 38372523, 38372525, 38372526, 38372527, 38372528, 38372530, 38372531, 38372532, 38372533, 38372534, 38372535, 38372537, 38372538, 38372541, 38372543, 38373599, 38373600, 38373601, 38373602, 38373603, 38373604, 38373605, 38373606, 38373607, 38373608, 38373609, 38373610, 38373611, 38373612, 38373613, 38373614, 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38448522.38449344, 38449345, 38449346, 38449347, 38449348, 38449352, 38449357, 38449358, 38449359, 38449360, 38449362, 38449363, 38449364, 38449365, 38449367, 38449369, 38449370, 38449371, 38449374, 38449377, 38449378, 38449379, 38449381, 38449382, 38449384, 38449385, 38449387, 38449388, 38449390, 38449391, 38449392, 38449394, 38449400, 38449410, 38458601, 38458602, 38458603, 38458604, 38458605, 38458606, 38458608, 38458609, 38458610, 38458667, 38458668, 38458669, 38458671, 38458672, 38458673, 38458675, 38458676, 38458677, 38458678, 38458679, 38458680, 38458681, 38458683, 38458684, 38458685, 38458686, 38458687, 38458688, 38458690, 38458691, 38458695, 38458696, 38458697, 38458698, 38458700, 38458702, 38462717, 38472556, 38472557, 38472559, 38472560, 38472561, 38472562, and 38472569.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.
  • Descripción del producto
    Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. || The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols.
  • Manufacturer