Devices

Device Recall LIFEPAK 15 Monitor/Defibrillator

  • 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, 37808592, 37808593, 37808595, 37808596, 37808597, 37808598, 37808599, 37808600, 37810775, 37810776, 37810777, 37810778, 37810779, 37810780, 37810781, 37810782, 37810783, 37810784, 37810785, 37810786, 37810787, 37810788, 37810789, 37810819, 37810820, 37810821, 37810823, 37811957, 37811958, 37811959, 37811960, 37811961, 37811962, 37811963, 37811964, 37811966, 37811967, 37811969, 37811970, 37811971, 37811972, 37812496, 37812497, 37812498, 37812499, 37812500, 37812501, 37812502, 37812503, 37812504, 37812505, 37812506, 37812507, 37812508, 37812509, 37812510, 37869570, 37869571, 37869572, 37869574, 37869575, 37869576, 37869578, 37869580, 37869582, 37869583, 37869784, 37869785, 37869786, 37869787, 37869788, 37869789, 37869790, 37869791, 37869792, 37869793, 37869800, 37869801, 37869808, 37869809, 37869810, 37869811, 37869812, 37869814, 37869815, 37869816, 37869817, 37869818, 37869820, 37869821, 37869822, 37869823, 37869824, 37869825, 37869826, 37869827, 37869828, 37869829, 37870210, 37870211, 37870212, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870245, 37870247, 37870249, 37870250, 37870252, 37870254, 37870255, 37870258, 37870259, 37870260, 37900478, 37900488, 37900602, 37900603, 37900604, 37900608, 37900610, 37900612, 37900615, 37900616, 37900617, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923078, 37923087, 37923100, 37923112, 37923125, 37923155, 37923156, 37923162, 37923201, 37923203, 37923204, 37923205, 37923206, 37923207, 37923208, 37923210, 37923211, 37923213, 37923214, 37924152, 37924153, 37924154, 37924155, 37924156, 37924160, 37924163, 37924164, 37924165, 37928454, 37928455, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928794, 37928958, 37928960, 37928961, 37928964, 37928967, 37928968, 37930940, 37930942, 37930944, 37930946, 37930948, 37930953, 37930960, 37930962, 37930964, 37930966, 37930968, 37930970, 37930972, 37930974, 37930976, 37930977, 37930979, 37930982, 37930983, 37930984, 37930986, 37930987, 37930988, 37930989, 37930990, 37930991, 37930992, 37930993, 37930994, 37930995, 37930996, 37930997, 37931000, 37931001, 37931003, 37931004, 37931005, 37933237, 37933238, 37933240, 37933241, 37933242, 37933243, 37933244, 37933245, 37933246, 37933247, 37933248, 37933249, 37933250, 37933251, 37933252, 37933253, 37933254, 37933256, 37933257, 37933259, 37933260, 37933261, 37933262, 37933263, 37933264, 37933265, 37933266, 37933267, 37933268, 37933269, 37933271, 37933273, 37933275, 37933276, 37933277, 37933278, 37933279, 37933280, 37937842, 37937843, 37937844, 37937845, 37937846, 37937847, 37937848, 37937849, 37937850, 37937851, 37937852, 37937854, 37937855, 37937856, 37937862, 37937863, 37937864, 37937865, 37937866, 37937867, 37937868, 37937869, 37937870, 37937871, 37937872, 37937873, 37937874.37937881, 37937883, 37937884, 37937885, 37937886, 37937887, 37937889, 37937890, 37937891, 37937892, 37937893, 37937894, 37937895, 37937896, 37949523, 37949524, 37949525, 37949526, 37949527, 37949528, 37949529, 37949530, 37949531, 37949532, 37949533, 37949534, 37949535, 37949536, 37949537, 37949538, 37949539, 37949540, 37949541, 37949542, 37949543, 37949544, 37949545, 37949546, 37949547, 37949548, 37949549, 37949550, 37949551, 37949552, 37949554, 37949558, 37949559, 37949560, 37949561, 37949562, 37949563, 37949564, 37949565, 37949566, 37952557, 37952558, 37952559, 37952560, 37952561, 37952563, 37952564, 37952565, 37952566, 37952567, 37952568, 37952569, 37952570, 37952571, 37952572, 37952573, 37952574, 37952576, 37952580, 37952581, 37952582, 37952583, 37952584, 37952585, 37952586, 37952587, 37952588, 37952589, 37952590, 37952591, 37952592, 37952593, 37952594, 37952595, 37955465, 37955466, 37955467, 37955468, 37955469, 37955470, 37955471, 37955472, 37955474, 37955475, 37955476, 37955477, 37955478, 37955479, 37955483, 37955491, 37955492, 37955493, 37955494, 37955495, 37955497, 37955499, 37955500, 37955501, 37955502, 37955508, 37955509, 37955510, 37955512, 37955513, 37955514, 37955516, 37955517, 37955518, 37955519, 37955521, 37955523, 37963250, 37963292, 37963295, 37963300, 37963302, 37963303, 37963322, 37963323, 37963324, 37963325, 37963327, 37963328, 37963329, 37963923, 37963926, 37963927, 37963928, 37963929, 37963930, 37963931, 37963932, 37963935, 37964552, 37964554, 37964557, 37964559, 37964560, 37964561, 37964564, 37964565, 37964567, 37964569, 37964575, 37964585, 37964587, 37964588, 37964589, 37964591, 37964594, 37964596, 37964599, 37964600, 37964601, 37964607, 37964608, 37964609, 37964610, 37964613, 37964614, 37964615, 37964617, 37964618, 37964621, 37964622, 37964623, 37964626, 37964628, 37964629, 37964630, 37968304, 37968306, 37968321, 37968323, 37968326, 37968422, 37968424, 37968425, 37968427, 37968429, 37968715, 37968716, 37968717, 37968718, 37968721, 37968722, 37968724, 37976542, 37976544, 37976545, 37976551, 37977472, 37977473, 37977475, 37977476, 37977477, 37977478, 38006814, 38006832, 38006833, 38006834, 38006836, 38006837, 38006838, 38006839, 38006841, 38046540, 38046542, 38046543, 38046544, 38046546, 38046548, 38046549, 38046550, 38046552, 38046553, 38046555, 38046556, 38046557, 38046558, 38046559, 38046561, 38046563, 38046564, 38046565, 38046566, 38046568, 38046569, 38046571, 38046572, 38046573, 38051946, 38051949, 38051950, 38051951, 38051952, 38051954, 38051955, 38051956, 38051957, 38051958, 38051960, 38051961, 38051962, 38051963, 38051964, 38051965, 38051967, 38051969, 38051970, 38051971, 38051972, 38051973, 38051974, 38051975, 38051977, 38051979, 38051980, 38051983, 38051990, 38051992, 38051993, 38051994, 38051995, 38051996, 38052002, 38052003, 38052004, 38052006, 38052008, 38052009, 38052012, 38052014, 38053197, 38053198, 38053199, 38053200, 38053201, 38053203, 38053204, 38053209, 38053210, 38053211, 38053213, 38053215, 38053216, 38053217, 38053218, 38053219, 38053220, 38053221, 38053224, 38053225, 38053229, 38053230, 38053231, 38053233, 38053234, 38053236, 38053237, 38053239, 38053241, 38053246, 38053247, 38053248, 38059562, 38059568, 38059570, 38059571, 38059573, 38059574, 38059575, 38059576, 38059578, 38059582, 38059588, 38059589, 38059591, 38059593, 38059595, 38059596, 38059598, 38059600, 38059602, 38059603, 38059604, 38059605, 38059606, 38059607, 38059608, 38062627, 38062630, 38069610, 38120768, 38120769, 38120770, 38120771, 38120772, 38120773, 38120774, 38120775, 38120776, 38120777, 38120779, 38120780, 38120781, 38120782, 38120783, 38120784, 38120785, 38120786, 38120787, 38120788, 38120789, 38120790, 38120791, 38124016, 38124017, 38124018, 38124019, 38124020, 38124022, 38124027, 38124028, 38124029, 38124030, 38124031, 38124032, 38124033, 38124034, 38124035, 38124036, 38124041, 38124042, 38124043, 38124044, 38124046, 38124047, 38124048, 38124049, 38125969, 38125970, 38125971, 38125972, 38125973, 38125974.38125975, 38125976, 38125977, 38125978, 38125979, 38125980, 38125981, 38125982, 38125983, 38125984, 38125985, 38125986, 38125987, 38125988, 38125989, 38125990, 38125991, 38125994, 38126252, 38126253, 38126254, 38126255, 38126256, 38126257, 38126258, 38126259, 38126260, 38126261, 38126262, 38126263, 38126265, 38126267, 38126268, 38126269, 38126270, 38126271, 38126272, 38126273, 38126274, 38126276, 38126277, 38127128, 38127130, 38127131, 38127132, 38127133, 38127134, 38127135, 38127136, 38127137, 38127138, 38127139, 38127140, 38127141, 38127143, 38127144, 38127145, 38127146, 38127147, 38129758, 38130272, 38130273, 38130275, 38130276, 38130277, 38130278, 38130279, 38130280, 38130281, 38130282, 38130283, 38130284, 38130285, 38130286, 38130287, 38131588, 38131589, 38131591, 38131592, 38131597, 38131598, 38131599, 38131600, 38131602, 38131603, 38131605, 38131606, 38131607, 38131608, 38131756, 38131757, 38131758, 38131759, 38131760, 38131761, 38131762, 38131763, 38131764, 38131765, 38131767, 38131768, 38131769, 38131770, 38131772, 38131773, 38131774, 38131775, 38131776, 38131777, 38131779, 38131781, 38131782, 38131842, 38131843, 38131844, 38131845, 38131937, 38132365, 38132366, 38132368, 38132370, 38132371, 38132653, 38132947, 38132948, 38132950, 38132951, 38132953, 38132954, 38133884, 38133885, 38133886, 38133887, 38133888, 38134508, 38134510, 38134511, 38134512, 38134515, 38134516, 38134517, 38134518, 38134520, 38134521, 38134522, 38134523, 38134524, 38134525, 38135120, 38135127, 38135171, 38135181, 38135186, 38135198, 38135205, 38135210, 38135211, 38135212, 38135213, 38135214, 38135215, 38135216, 38135217, 38135218, 38135219, 38135220, 38135221, 38136504, 38136505, 38136506, 38136507, 38136508, 38136509, 38136510, 38136512, 38136513, 38136514, 38136515, 38136516, 38136517, 38136518, 38136519, 38136520, 38136522, 38136523, 38137115, 38137116, 38137122, 38137134, 38137136, 38137137, 38137138, 38137143, 38137149, 38137155, 38137156, 38137161, 38137168, 38137174, 38137178, 38138844, 38138845, 38138846, 38141001, 38141002, 38141003, 38141004, 38141005, 38141006, 38141007, 38141008, 38141009, 38141010, 38141012, 38141014, 38141015, 38141016, 38141017, 38141018, 38141020, 38141023, 38141025, 38141027, 38141028, 38142062, 38142064, 38142065, 38142067, 38142068, 38142070, 38142071, 38142073, 38142077, 38142079, 38142559, 38142564, 38142565, 38142566, 38142567, 38142568, 38142569, 38142574, 38142575, 38142741, 38142742, 38142743, 38142941, 38142943, 38142944, 38142945, 38142946, 38142947, 38142948, 38142949, 38142950, 38142951, 38142952, 38143265, 38143266, 38143268, 38143269, 38143270, 38143272, 38143274, 38143275, 38143276, 38143277, 38143279, 38143280, 38143282, 38143288, 38143289, 38143290, 38143291, 38143292, 38143294, 38143296, 38143297, 38143298, 38143299, 38143300, 38143301, 38143302, 38143843, 38143844, 38143845, 38145711, 38145723, 38145724, 38147665, 38147670, 38147673, 38147680, 38147681, 38147682, 38147683, 38147684, 38147687, 38147688, 38147689, 38148017, 38148019, 38148020, 38148021, 38148026, 38148028, 38148031, 38148032, 38148033, 38148034, 38148035, 38148040, 38148041, 38148043, 38148045, 38148047, 38148048, 38148050, 38148051, 38148053, 38148054, 38148056, 38148057, 38148059, 38148060, 38148061, 38148062, 38148063, 38148065, 38148066, 38148067, 38148068, 38148069, 38148070, 38148072, 38148073, 38148074, 38148076, 38148079, 38148080, 38148081, 38148082, 38148083, 38148084, 38148085, 38148086, 38148088, 38150685, 38150687, 38150688, 38150691, 38150692, 38150693, 38150694, 38150695, 38150696, 38150697, 38150700, 38150701, 38150704, 38150705, 38150706, 38150707, 38150708, 38150709, 38150710, 38151892, 38151893, 38151894, 38151895, 38151896, 38151897, 38151898, 38151899, 38153123, 38153124, 38153126, 38153127, 38153128, 38153130, 38153131, 38153132, 38153133, 38153134, 38153135, 38153136, 38153138, 38153140, 38153141, 38153142, 38153143, 38153864, 38153865, 38153866, 38153867, 38153870, 38153871, 38153876, 38153877, 38153878.38153879, 38153880, 38153881, 38153884, 38153888, 38153889, 38153890, 38153891, 38153892, 38154511, 38154513, 38154514, 38154515, 38154516, 38154517, 38154518, 38154519, 38154520, 38154521, 38154522, 38154523, 38154524, 38154525, 38155371, 38155372, 38155376, 38155378, 38155379, 38155380, 38155381, 38155382, 38155850, 38155851, 38155856, 38155857, 38155864, 38155865, 38155882, 38155889, 38155900, 38155905, 38155906, 38155907, 38155911, 38155912, 38155913, 38155914, 38155918, 38155919, 38155920, 38155924, 38156569, 38156570, 38156571, 38156573, 38156574, 38156575, 38157896, 38157897, 38157899, 38157900, 38157901, 38157903, 38157904, 38157905, 38157906, 38157907, 38157908, 38157909, 38157910, 38157911, 38157912, 38157913, 38157914, 38157915, 38157916, 38157917, 38158071, 38158072, 38158074, 38158075, 38158076, 38158078, 38158079, 38158080, 38158081, 38158082, 38158083, 38158084, 38158085, 38158086, 38158087, 38158088, 38158089, 38158090, 38158091, 38159137, 38159138, 38159139, 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  • Clasificación del producto
    Cardiovascular Devices
  • 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
    Physio Control, Inc.
  • 1 Event

Fabricante

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

Dispositivo con un nombre similar

Más información acerca de la data acá

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
    Cardiovascular Devices
  • 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
    Physio-Control, Inc.