Devices

Device Recall LIFEPAK 15 Monitor/Defibrillator

  • Model / 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
    Physio-Control, Inc.
  • 1 Event

Manufacturer

Physio-Control, Inc.
  • Manufacturer Address
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall LIFEPAK 15 Monitor/Defibrillator
  • Model / 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, 38365769, 38365770, 38365771, 38365772, 38365937, 38365938, 38365939, 38365940, 38365941, 38365942, 38365943, 38365944, 38365945, 38365946, 38365946, 38368303, 38368304, 38368305, 38368306, 38368307, 38368308, 38368309, 38368310, 38368311, 38368312, 38368313, 38368314, 38368315, 38368316, 38368318, 38368323, 38368325, 38368326, 38368327, 38368329, 38368607, 38368608, 38368609, 38368610, 38368611, 38368612, 38368613, 38368614, 38368615, 38368616, 38368617, 38368618, 38368619, 38368620, 38368621, 38368622, 38368623, 38368624, 38368625, 38368627, 38369575, 38369576, 38369576, 38369578, 38369579, 38369580, 38369581, 38369582, 38369583, 38369584, 38369585, 38369586, 38369587, 38369588, 38369588, 38369589, 38369590, 38369591, 38369592, 38369593, 38369594, 38369595, 38370269, 38370270, 38370271, 38370272, 38370273, 38370274, 38370275, 38370276, 38370277, 38370278, 38370280, 38370281, 38370282, 38370283, 38370284, 38370285, 38370288, 38370290, 38370291, 38370293, 38370423, 38370424, 38370425, 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, 38373615, 38373616, 38373617, 38373618, 38374115, 38374116, 38374117, 38374118, 38374119, 38374120, 38374121, 38374122, 38374123, 38374125, 38374126, 38374127, 38374129, 38374130, 38374131, 38374132, 38374134, 38374135, 38374136, 38374138, 38374678, 38374679, 38374680, 38374681, 38374682, 38374683, 38374684, 38374686, 38374687, 38374688, 38374689, 38374690, 38374691, 38374692, 38374693, 38374696, 38374697, 38374698, 38374700, 38374701, 38388120, 38388121, 38388122, 38388123, 38388125, 38388126, 38388127, 38388129, 38388147, 38388149, 38388150, 38388152, 38392628, 38392629, 38392630, 38392632, 38392633, 38392634, 38392635, 38392636, 38392637, 38392638, 38400871, 38400873, 38400874, 38400880, 38400881, 38400882, 38400883, 38400884, 38407036, 38407037, 38407038, 38407039, 38407041, 38407147, 38407148, 38407149, 38407150, 38407151, 38407152, 38407153, 38407154, 38407155, 38407156, 38407157, 38407158, 38407159, 38407160, 38407161, 38407162, 38407163, 38407164, 38407170, 38407172, 38407173, 38407174, 38407175, 38407176, 38407177, 38407178, 38407179, 38407180, 38407181, 38407182, 38407183, 38407185, 38407188, 38407190, 38407191, 38407192, 38407193, 38407194, 38407195, 38407196, 38407530, 38407531, 38407533, 38407534, 38407535, 38410842, 38410843, 38410845, 38410846, 38410847, 38410848, 38410849, 38410850, 38410851, 38410852, 38410854, 38410855, 38410856, 38410857, 38410858, 38410860, 38410861, 38410862, 38410864, 38410865, 38410866, 38410868, 38410869, 38410872, 38410873, 38415389, 38415391, 38415392, 38415394, 38415395, 38415407, 38415408, 38415410, 38415411, 38415412, 38417308, 38418568, 38418570, 38418571, 38418572, 38418581, 38418583, 38418584, 38418585, 38418586, 38418588, 38418589, 38418590, 38418591, 38418592, 38418593, 38418594, 38418595, 38418596, 38418597, 38418598, 38418598, 38418599, 38418601, 38418602, 38418603, 38418604, 38418604, 38418605, 38418606, 38418607, 38418608, 38418609, 38418610, 38418611, 38418612, 38418613, 38428175, 38428176, 38428177, 38428178, 38428179, 38428180, 38428181, 38428182, 38428183, 38428184, 38428185, 38428188, 38428189, 38428190, 38428191, 38428192, 38428193, 38428194, 38428195, 38428196, 38432094, 38432094, 38432100, 38432100, 38432101, 38432102, 38432103, 38432104, 38432105, 38432105, 38441911, 38441912, 38441913, 38441914, 38441915, 38441916, 38441917, 38441918, 38441919, 38441920, 38441921, 38441922, 38441922, 38441923, 38441925, 38441926, 38441927, 38441928, 38441929, 38441930, 38441931, 38441932, 38441933, 38441934, 38441935, 38441936, 38445572, 38445573, 38445574, 38445579, 38445580, 38445581, 38445582, 38445583, 38445584, 38445585, 38445590, 38445591, 38445593, 38445594, 38445595, 38445597, 38445599, 38445601, 38445604, 38445607, 38445611, 38445615, 38445619, 38445624, 38445626, 38445627, 38445630, 38445638, 38445640, 38445641, 38445646, 38445649, 38445650, 38445651, 38445652, 38448508, 38448509, 38448510, 38448511, 38448512, 38448513, 38448514, 38448515, 38448516, 38448517, 38448518, 38448520, 38448521, 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.
  • Product Description
    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
    Physio Control, Inc.