Device Recall LIFEPAK Express AED

  • Model / Serial
    PART NUMBER: 3202177-000, 3202177-001, 3202177-002, 3202177-006, 3202177-024, 3202177-026, 3202177-046, 3202177-066, 3202177-080, 3202177-086, and 3202177-106; SERIAL NUMBER: 35057999, 35558399, 35057996, 35076760, 35086872, 35086873, 35086874, 35086875, 35086876, 35086877, 35086878, 35086879, 35086880, 35086881, 35087002, 35087003, 35087004, 35112123, 35120681, 35120682, 35120683, 35174476, 35174477, 35174478, 35174479, 35174487, 35189989, 35190004, 35190371, 35190372, 35237901, 35363559, 35388553, 35415805, 35457181, 35606013, 35627387, 35667618, 35702342, 35843530, 36084979, 36106000, 35086839, 35142569, 35142570, 35142571, 35142572, 35142573, 35142574, 35266844, 35266845, 35266878, 35266879, 35266881, 35266883, 35266884, 35266886, 35266887, 35266888, 35266889, 35266890, 35266891, 35266892, 35266893, 35266899, 35266900, 35314291, 35416139, 35450316, 35450324, 35058947, 35058948, 35058949, 35058950, 35058951, 35058952, 35058953, 35058954, 35058956, 35058958, 35058961, 35058968, 35058969, 35058970, 35058971, 35058972, 35058981, 35058982, 35058986, 35058988, 35058993, 35058994, 35058999, 35059002, 35060160, 35060308, 35060309, 35060310, 35060311, 35060312, 35060313, 35060314, 35060315, 35060316, 35060317, 35060589, 35060721, 35060961, 35061061, 35061139, 35061205, 35061206, 35061207, 35064900, 35064901, 35064902, 35064903, 35064904, 35064905, 35064907, 35064908, 35064909, 35064910, 35064911, 35064912, 35064913, 35064914, 35064915, 35064916, 35064917, 35064918, 35064919, 35064920, 35064921, 35064922, 35064923, 35064924, 35064925, 35064926, 35064927, 35064928, 35064929, 35064930, 35064931, 35064932, 35064933, 35064934, 35064935, 35064936, 35064937, 35064938, 35064939, 35064940, 35064941, 35064942, 35064943, 35064944, 35064945, 35064946, 35064947, 35064948, 35064949, 35064950, 35064951, 35064952, 35064953, 35064954, 35064955, 35064956, 35064957, 35064958, 35064959, 35064960, 35064961, 35064962, 35064963, 35064964, 35064965, 35064966, 35064967, 35064968, 35064969, 35064970, 35064971, 35064972, 35064973, 35064974, 35064975, 35065305, 35065306, 35065307, 35065308, 35065309, 35065310, 35065311, 35065312, 35065313, 35065314, 35065315, 35065316, 35065317, 35065318, 35065319, 35065320, 35065321, 35065325, 35065327, 35065336, 35065337, 35065338, 35065379, 35065381, 35065384, 35065385, 35065392, 35065393, 35065394, 35065395, 35065396, 35065397, 35065400, 35065401, 35065403, 35065408, 35065411, 35066342, 35066343, 35066464, 35074843, 35074861, 35074863, 35074866, 35074867, 35074868, 35074869, 35074870, 35074871, 35074872, 35075602, 35075604, 35075605, 35075606, 35075607, 35075608, 35075609, 35075610, 35075611, 35075612, 35075613, 35075615, 35075616, 35075617, 35075618, 35075619, 35075620, 35075621, 35075622, 35075624, 35075626, 35075627, 35075628, 35075629, 35075630, 35075631, 35075632, 35075633, 35075634, 35075637, 35075638, 35075639, 35075640, 35075641, 35075642, 35075643, 35075644, 35075645, 35075646, 35075647, 35075648, 35075649, 35075650, 35075651, 35075652, 35075653, 35075654, 35075655, 35075662, 35075663, 35075664, 35075665, 35075666, 35075667, 35075668, 35075669, 35075670, 35075671, 35075672, 35075673, 35075674, 35075675, 35075676, 35075677, 35075678, 35075679, 35075680, 35075681, 35075682, 35075683, 35075684, 35075685, 35076506, 35076756, 35076757, 35076766, 35076767, 35076768, 35076769, 35076820, 35076821, 35076822, 35076823, 35076824, 35076825, 35076826, 35076827, 35076829, 35076830, 35076831, 35076832, 35076833, 35076834, 35076835, 35076836, 35076837, 35076838, 35076839, 35076840, 35076841, 35076842, 35076843, 35076844, 35076845, 35076846, 35076847, 35076848, 35076849, 35076850, 35076851, 35076852, 35076853, 35076854, 35076855, 35076856, 35076857, 35076858, 35076859, 35076860, 35076861, 35076862, 35076863, 35076864, 35076865, 35076866, 35076867, 35076868, 35076869, 35076870, 35077750, 35079092, 35079093, 35079094, 35079095, 35079096, 35079097, 35079098, 35079099, 35079100, 35079101, 35079102, 35079103, 35079104, 35079105, 35079106, 35079108, 35081319, 35081320, 35081321, 35081322, 35081323, 35081332, 35081333, 35081334, 35081335, 35081336, 35081337, 35081338, 35081339, 35081340, 35081342, 35081344, 35081345, 35081346, 35081347, 35081348, 35081349, 35081350, 35081351, 35081352, 35081354, 35081356, 35081357, 35081358, 35081360, 35081442, 35081443, 35081444, 35081445, 35081446, 35081447, 35081448, 35081449, 35081450, 35081451, 35081452, 35081453, 35081454, 35081455, 35081456, 35081457, 35081458, 35081459, 35081460, 35081461, 35081462, 35081463, 35081464, 35081465, 35081466, 35081467, 35081468, 35081469, 35081470, 35081471, 35081472, 35081473, 35081474, 35081475, 35081476, 35081477, 35081478, 35081479, 35081480, 35081481, 35081482, 35081483, 35081484, 35081485, 35081486, 35081487, 35081488, 35081489, 35081490, 35081491, 35081492, 35081493, 35081494, 35081495, 35081496, 35081497, 35081498, 35081499, 35081500, 35081501, 35081502, 35081503, 35081504, 35081506, 35081507, 35081508, 35081509, 35081510, 35081511, 35081512, 35081513, 35081514, 35081516, 35081517, 35081518, 35081519, 35081520, 35081521, 35081522, 35081523, 35081524, 35081525, 35081526, 35081527, 35081528, 35081529, 35081530, 35081532, 35081533, 35081534, 35081535, 35081536, 35081537, 35081538, 35081539, 35081540, 35081541, 35081542, 35081543, 35081544, 35081545, 35081546, 35081547, 35081548, 35081549, 35081550, 35081551, 35081552, 35081553, 35081554, 35081555, 35081557, 35081558, 35081559, 35081560, 35081561, 35081562, 35081563, 35081564, 35081565, 35081566, 35081567, 35081568, 35081569, 35081570, 35081571, 35081572, 35081573, 35081574, 35081575, 35081576, 35081577, 35081578, 35081579, 35081580, 35081581, 35081582, 35081583, 35081584, 35081585, 35081586, 35081587, 35081588, 35081589, 35081590, 35081591, 35081592, 35081593, 35081594, 35081595, 35081596, 35081597, 35081598, 35081599, 35081601, 35081602, 35081603, 35081604, 35081605, 35081606, 35081607, 35081608, 35081609, 35084506, 35084507, 35084699, 35084700, 35084701, 35084702, 35084703, 35084704, 35084705, 35084861, 35084862, 35084895, 35085212, 35085217, 35085222, 35085313, 35086860, 35086987, 35086988, 35086989, 35119386, 35119387, 35119388, 35119389, 35119390, 35119391, 35119392, 35119393, 35119394, 35119395, 35119396, 35119397, 35119398, 35119399, 35119400, 35119401, 35119402, 35119403, 35119404, 35119405, 35127147, 35127148, 35135990, 35135991, 35136661, 35136662, 35136675, 35136682, 35136689, 35136690, 35142494, 35142495, 35142496, 35142497, 35142498, 35142499, 35142500, 35142686, 35142696, 35142697, 35142698, 35142702, 35142703, 35142704, 35142705, 35142706, 35142709, 35142711, 35142725, 35142727, 35142728, 35142729, 35142730, 35142731, 35142732, 35142733, 35142734, 35142741, 35142744, 35142751, 35142752, 35142753, 35142754, 35142755, 35142762, 35142764, 35142765, 35142767, 35164275, 35165280, 35165459, 35165460, 35165462, 35165463, 35165465, 35165466, 35165467, 35165470, 35165473, 35165474, 35165475, 35165476, 35165478, 35165479, 35165481, 35165482, 35165483, 35165484, 35165485, 35165486, 35165881, 35165882, 35165883, 35165885, 35165889, 35165890, 35165894, 35165895, 35166530, 35166555, 35166561, 35166662, 35166667, 35166668, 35166669, 35173005, 35180729, 35180730, 35180731, 35180732, 35180733, 35180734, 35180735, 35180736, 35180737, 35180738, 35180739, 35180740, 35180741, 35180742, 35180743, 35180744, 35180745, 35180746, 35180747, 35180748, 35180749, 35180750, 35180752, 35180753, 35180755, 35180756, 35180757, 35180758, 35180759, 35180760, 35180761, 35180762, 35180763, 35180764, 35180765, 35180766, 35180767, 35180768, 35180769, 35180770, 35182559, 35188809, 35188848, 35188851, 35188853, 35188855, 35188858, 35188860, 35188863, 35188865, 35188868, 35188870, 35188872, 35188874, 35188876, 35188878, 35188881, 35188884, 35188891, 35188895, 35189847, 35189982, 35189994, 35190002, 35190012, 35190021, 35190045, 35190057, 35190065, 35190071, 35190072, 35190076, 35190077, 35190078, 35200862, 35200863, 35200866, 35200867, 35200869, 35200871, 35200873, 35200875, 35200877, 35200880, 35200882, 35200884, 35200887, 35200889, 35200891, 35200894, 35200895, 35200916, 35200917, 35200918, 35200919, 35200920, 35200921, 35200922, 35200923, 35200924, 35200925, 35200926, 35200927, 35200928, 35200929, 35200930, 35200931, 35200932, 35200933, 35200934, 35200935, 35213744, 35213746, 35213749, 35213751, 35219822, 35219823, 35219824, 35219825, 35219826, 35219827, 35219828, 35219829, 35219830, 35219831, 35219832, 35219833, 35219834, 35219835, 35219836, 35219837, 35219838, 35219839, 35219840, 35219841, 35219842, 35219843, 35219844, 35219846, 35219847, 35219848, 35219849, 35219850, 35219851, 35219852, 35219853, 35219854, 35219855, 35219856, 35219857, 35219858, 35219859, 35219860, 35219861, 35219862, 35219863, 35219864, 35219865, 35219866, 35219867, 35219868, 35219869, 35219870, 35219871, 35219872, 35219873, 35219874, 35219875, 35219876, 35219877, 35219878, 35219879, 35219880, 35219881, 35219882, 35219883, 35219884, 35219885, 35219886, 35219887, 35219888, 35219889, 35219890, 35219891, 35219892, 35219893, 35219894, 35219895, 35219896, 35219897, 35219898, 35219899, 35219900, 35219901, 35219902, 35219903, 35219904, 35219905, 35219906, 35219907, 35219908, 35219909, 35219910, 35219911, 35219912, 35219913, 35219914, 35219915, 35219916, 35219917, 35219918, 35219919, 35219920, 35219921, 35219922, 35219923, 35219925, 35219926, 35219927, 35219928, 35219929, 35219930, 35219931, 35219932, 35219933, 35219934, 35219935, 35219936, 35219937, 35219938, 35219939, 35219940, 35219941, 35219942, 35219943, 35219944, 35219945, 35219946, 35219947, 35219948, 35219949, 35219950, 35219951, 35219952, 35219953, 35219954, 35219955, 35219956, 35219957, 35219958, 35219959, 35219960, 35219961, 35219962, 35219963, 35219964, 35219965, 35219966, 35219967, 35219968, 35219969, 35219970, 35219971, 35219972, 35219973, 35219974, 35219975, 35219976, 35219977, 35219978, 35219979, 35219980, 35219981, 35219982, 35219983, 35219984, 35219985, 35219986, 35219987, 35219988, 35219989, 35219990, 35219991, 35219992, 35219993, 35219994, 35219995, 35219996, 35219997, 35219998, 35219999, 35220000, 35220001, 35220002, 35220003, 35220004, 35220005, 35220006, 35220007, 35220009, 35220010, 35220011, 35220012, 35220013, 35220014, 35220015, 35220016, 35220017, 35220018, 35220019, 35220020, 35220021, 35220022, 35220023, 35220024, 35220025, 35220026, 35220027, 35220028, 35220029, 35220030, 35220031, 35220032, 35220033, 35220034, 35220035, 35220036, 35220037, 35220038, 35220039, 35220040, 35220041, 35220042, 35220043, 35220044, 35220045, 35220046, 35220047, 35220048, 35220049, 35220050, 35220051, 35220052, 35220053, 35220643, 35220644, 35220645, 35220646, 35220647, 35220649, 35220651, 35220655, 35220656, 35220657, 35220663, 35220664, 35220666, 35220668, 35220708, 35232342, 35232346, 35232352, 35232358, 35232362, 35232364, 35237919, 35237920, 35237921, 35237922, 35237923, 35237924, 35237926, 35237927, 35237928, 35237929, 35237930, 35243430, 35450318, 35450322, 35527546, 35573219, 35582098, 35589905, 35606041, 35627778, 35882828, 35882831, 35889950, 35906079, 35927909, 35927913, 35927915, 35927918, 35988794, 35988795, 35988797, 35988798, 35988799, 35988800, 35988801, 35988802, 35988803, 35988804, 35988805, 35988806, 35988807, 35988808, 35988809, 35988810, 35988811, 35988812, 35988813, 35988814, 35988815, 35988816, 35988817, 35988818, 35988819, 35988820, 35988821, 35988822, 35988823, 35988824, 35988825, 35988826, 35988827, 35988828, 35988829, 35988830, 35988831, 35988837, 35992978, 35992991, 35992996, 35992997, 35992998, 35993000, 35993011, 35993028, 35993031, 35993033, 36085007, 36103006, 36103012, 36103013, 36103015, 36103016, 36103017, 36103022, 36103028, 36103029, 36103030, 36103033, 36121401, 36121402, 36121403, 36138709, 36151002, 36151004, 36151006, 36151007, 36151008, 36151009, 36151010, 36151011, 36151012, 36151013, 36151014, 36151015, 36151016, 36151017, 36151018, 36151019, 36154390, 36154391, 36154392, 36154393, 36154394, 36154395, 36154396, 36154397, 36154398, 36154399, 36154400, 36154401, 36154402, 36154403, 36154404, 36154405, 36154406, 36154407, 36154408, 36154410, 36154411, 36154412, 36154413, 36154414, 36154415, 36154416, 36154417, 36154418, 36154419, 36154420, 36154421, 36154422, 36154467, 36154468, 36154469, 36154470, 36154471, 36154472, 36154473, 36154474, 36154475, 36154476, 36154477, 36154478, 36154479, 36154481, 36154482, 36154483, 36154484, 36154490, 36358206, 36358208, 36358209, 35232338, 35140669, 35140672, 35189992, 35270549, 35270550, 35270551, 35288235, 35346019, 35362977, 35362978, 35362979, 35377871, 35408792, 35424159, 35424160, 35424161, 35424162, 35424163, 35424164, 35424165, 35424166, 35424167, 35424168, 35452838, 35452839, 35452840, 35452841, 35452842, 35452844, 35452845, 35452846, 35452860, 35469945, 35494575, 35566908, 35566911, 35601550, 35601551, 35602423, 35616846, 35616849, 35616850, 35616856, 35616857, 35616858, 35616862, 35711122, 35711123, 35711134, 35711141, 35711144, 35711145, 35711148, 35737235, 35737237, 35737239, 35892100, 35892107, 35892111, 35892112, 35892113, 35893568, 35893581, 35893582, 35893583, 35893584, 35893585, 35893586, 35893587, 35893588, 35893589, 35893590, 35957829, 35957832, 35957884, 35957885, 35957886, 35957892, 35957893, 35957894, 35957895, 35957897, 35957924, 35957926, 35957968, 35957969, 35972399, 35983054, 35983055, 35983056, 35983059, 35983060, 35983061, 35983062, 35983063, 35983064, 35983065, 35983066, 35983067, 35983068, 35983069, 35983070, 35983071, 35983072, 35983073, 35983074, 35983075, 35987947, 36121408, 36121410, 36121414, 36121428, 36234171, 36235067, 36307120, 36307121, 36307122, 36307130, 36328427, 36328429, 36328430, 36328431, 36328434, 36328435, 36263073, 35506587, 35506593, 35506594, 35506595, 35506596, 35506597, 35506598, 35506599, 35506600, 35506601, 35506602, 35506603, 35506604, 35506605, 35506606, 35506607, 35506608, 35506609, 35506610, 35506611, 35506612, 35506613, 35506614, 35506615, 35506616, 35506617, 35506618, 35506619, 35506620, 35506621, 35647495, 35647496, 35647497, 35647498, 35647499, 35647500, 35647501, 35647502, 35647503, 35647504, 35719649, 35719650, 35719651, 35719652, 35719653, 35719844, 35719845, 35719846, 35719847, 35719848, 35719849, 35756648, 35756649, 35756650, 35756651, 35894094, 35894095, 35894096, 35894097, 35894098, 35894099, 35894100, 35894101, 35894102, 35894103, 35894104, 35894105, 35894106, 35894107, 35957977, 35957983, 35957984, 35957985, 35957986, 36203676, 36203677, 36203678, 36203679, 36203680, 36203681, 36203682, 36203684, 36203685, 36203686, 36203687, 36203688, 36203689, 36203690, 36203691, 36203698, 36203699, 36203700, 36203701, 36203702, 36235080, 36235081, 36235082, 36235083, 36235084, 36235085, 36235087, 36235088, 36235089, 36235090, 36257929, 36257932, 36257933, 36257934, 36257935, 36257937, 36257938, 36257939, 36257940, 36257941, 36257943, 36257945, 36257946, 36257947, 36257949, 36257951, 36257952, 36257953, 36257954, 36257955, 36257956, 36257957, 36257959, 36257960, 36257961, 36257962, 36257963, 36257965, 36257966, 36257967, 36257968, 36257969, 36257973, 36257975, 36257976, 35401334, 36263074, 36263075, 36263076, 36263077, 35247955, 35247957, 35247959, 35247963, 35247965, 35247967, 35247969, 35295014, 35295018, 35295020, 35295022, 35295024, 35295026, 35295028, 35295031, 35295033, 35295035, 35295803, 35295807, 35295812, 35295818, 35295822, 35295826, 35295832, 35295837, 35295844, 35295850, 35295855, 35295858, 35295863, 35295866, 35295870, 35295875, 35295879, 35295882, 35295883, 35295886, 35295887, 35295888, 35295889, 35295890, 35295891, 35295892, 35295893, 35295894, 35295895, 35295896, 35295897, 35295898, 35295899, 35295900, 35295902, 35295903, 35295904, 35295905, 35295906, 35295907, 35295908, 35295916, 35295917, 35295918, 35295926, 35295927, 35295928, 35295929, 35295931, 35295932, 35295933, 35295939, 35295940, 35295941, 35295950, 35295951, 35295957, 35295958, 35295959, 35295964, 35402024, 35402025, 35402026, 35402027, 35402028, 35402029, 35402030, 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  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
  • Product Description
    LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. || LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
  • Manufacturer
  • 1 Event

Manufacturer

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