Device Recall The LIFEPAK 15 Monitor/Defibrillator (LP15)

  • Model / Serial
    LOT NUMBERS OF AFFECTED MODULE:  Lot # 1506, 1520, 1532, 1544, and 1551.  SERIAL NUMBERS OF AFFECTED DEVICES:  37930990, 38046566, 38130282, 38200467, 38374121, 38544771, 38561025, 38567823, 38577667, 38763423, 38805573, 39229417, 39656903, 39749477, 39757723, 39757723, 39905189, 40007558, 40007616, 40008237, 40074226, 40246186, 40637428, 40639397, 40881488, 41119327, 41441205, 41734558, 41908077, 42036185, 42721982, 42759819, 43273957, 43981182, 44128955, 44143195, 44143356, 44143399, 44143438, 44143481, 44143616, 44143674, 44143708, 44143786, 44143811, 44143814, 44143891, 44143894, 44143984, 44146278, 44146304, 44146408, 44148345, 44148588, 44148641, 44150897, 44151007, 44151084, 44151151, 44151156, 44151224, 44151362, 44151498, 44151591, 44151697, 44151790, 44151809, 44151862, 44151920, 44151995, 44152133, 44152249, 44152345, 44152361, 44156527, 44157048, 44157124, 44157189, 44157404, 44157697, 44157711, 44158485, 44158543, 44158614, 44158707, 44158804, 44159096, 44159162, 44159337, 44159406, 44159406, 44159491, 44159555, 44159615, 44159786, 44160212, 44166262, 44166304, 44166470, 44166503, 44166514, 44166523, 44166536, 44166547, 44166631, 44171950, 44174110, 44174285, 44174322, 44174756, 44175011, 44175045, 44175070, 44175103, 44179307, 44179460, 44179499, 44179545, 44179576, 44179644, 44179750, 44180084, 44180141, 44180381, 44180443, 44180522, 44180584, 44180619, 44180789, 44180819, 44180917, 44182111, 44182155, 44185896, 44185922, 44185964, 44186134, 44186190, 44186249, 44186332, 44186361, 44186435, 44186555, 44186767, 44186789, 44186823, 44186871, 44186922, 44186961, 44187023, 44187363, 44187401, 44187447, 44187475, 44187739, 44187787, 44188141, 44195485, 44195502, 44195519, 44195593, 44195691, 44195713, 44195735, 44195749, 44195756, 44195861, 44195948, 44196025, 44196065, 44196096, 44196147, 44196198, 44196225, 44196266, 44196325, 44196414, 44196485, 44196832, 44196858, 44196898, 44196974, 44197026, 44197066, 44197146, 44197168, 44197212, 44197274, 44197295, 44197327, 44197348, 44197382, 44197397, 44197467, 44197511, 44198596, 44198678, 44198865, 44198906, 44198922, 44198961, 44198976, 44199088, 44199223, 44199386, 44199424, 44199478, 44199525, 44199806, 44199969, 44200010, 44200055, 44200186, 44200649, 44200724, 44200766, 44200807, 44200910, 44201002, 44201062, 44201120, 44201156, 44201243, 44201301, 44201342, 44201384, 44201466, 44201500, 44201551, 44203033, 44203091, 44203121, 44203172, 44203200, 44203234, 44203258, 44203316, 44203327, 44203472, 44203564, 44203654, 44203856, 44203886, 44203969, 44204052, 44204268, 44204540, 44204717, 44204782, 44204853, 44205142, 44205292, 44205329, 44205365, 44205404, 44205516, 44205592, 44205633, 44205705, 44205764, 44205875, 44205960, 44206055, 44206131, 44206166, 44206245, 44207820, 44207861, 44207882, 44208048, 44208105, 44208127, 44208152, 44208202, 44208320, 44208450, 44208494, 44209302, 44209524, 44209555, 44209797, 44209919, 44210007, 44210219, 44210271, 44210344, 44210396, 44210473, 44210493, 44210544, 44210619, 44210911, 44210940, 44210957, 44210984, 44211004, 44211021, 44211321, 44211355, 44211394, 44219958, 44220117, 44220142, 44220340, 44220358, 44220381, 44220403, 44220534, 44220569, 44220650, 44220734, 44220757, 44220782, 44220818, 44220856, 44220881, 44220919, 44220947, 44221011, 44221083, 44221152, 44221229, 44221426, 44221458, 44221503, 44222683, 44222703, 44222723, 44224099, 44224106, 44224120, 44224121, 44224139, 44224146, 44224176, 44224178, 44224194, 44224197, 44224243, 44224269, 44224285, 44224295, 44224306, 44224314, 44224315, 44224414, 44224419, 44224559, 44224635, 44224743, 44224804, 44224845, 44224979, 44225033, 44225060, 44225117, 44225180, 44225227, 44225242, 44225258, 44225272, 44225368, 44225610, 44225663, 44225706, 44225860, 44225939, 44226003, 44226063, 44226136, 44226183, 44226221, 44226231, 44226283, 44226384, 44226403, 44226417, 44226480, 44226493, 44226528, 44226564, 44226612, 44226624, 44226654, 44228007, 44228009, 44228037, 44228039, 44228053, 44228067, 44228097, 44228156, 44228202, 44228323, 44228343, 44228393, 44228394, 44228414, 44228492, 44228537, 44228650, 44228651, 44228709, 44228769, 44228931, 44228938, 44229062, 44229105, 44229133, 44229265, 44229280, 44229317, 44229411, 44229494, 44229497, 44229587, 44229629, 44229633, 44229787, 44229803, 44229860, 44229937, 44230308, 44230365, 44230388, 44230433, 44230497, 44230585, 44230632, 44230665, 44230754, 44230805, 44230839, 44230878, 44230887, 44230994, 44231014, 44231022, 44231124, 44233217, 44233228, 44233240, 44233286, 44233351, 44233416, 44233429, 44233508, 44233533, 44233547, 44233568, 44233602, 44233606, 44233618, 44233620, 44233705, 44233707, 44233769, 44233779, 44233843, 44233869, 44233920, 44233922, 44233952, 44233985, 44234024, 44234047, 44234092, 44234109, 44234117, 44234164, 44234238, 44234262, 44234283, 44234408, 44234505, 44234642, 44234673, 44234683, 44234697, 44234702, 44234719, 44234726, 44234767, 44234771, 44234803, 44234820, 44234840, 44234843, 44234882, 44234924, 44235000, 44265548, 44276069, 44276070, 44276165, 44276362, 44276543, 44276578, 44276641, 44276717, 44276718, 44276742, 44276782, 44276790, 44276849, 44276872, 44276874, 44276910, 44276912, 44276965, 44276981, 44277009, 44277082, 44277610, 44277749, 44277789, 44277802, 44277815, 44277837, 44277855, 44278010, 44278016, 44278041, 44278072, 44278117, 44278123, 44278402, 44278406, 44278430, 44278517, 44278595, 44278639, 44278663, 44278810, 44278870, 44278930, 44278970, 44281241, 44281279, 44281287, 44281331, 44281393, 44281457, 44281541, 44281569, 44281620, 44281622, 44281656, 44281692, 44281702, 44281742, 44281902, 44281939, 44281953, 44282017, 44282096, 44282150, 44282184, 44282236, 44282280, 44282347, 44282366, 44282462, 44282483, 44282520, 44282551, 44282602, 44282602, 44282626, 44282718, 44282740, 44282832, 44282877, 44283199, 44283215, 44283255, 44283315, 44283337, 44283369, 44283388, 44283427, 44283499, 44283558, 44283561, 44283589, 44283762, 44283840, 44283849, 44283882, 44283988, 44284032, 44284190, 44287263, 44287264, 44293297, 44293371, 44294100, 44294203, 44294348, 44294417, 44294894, 44294965, 44295248, 44295351, 44295614, 44295900, 44295928, 44295983, 44296028, 44296201, 44302389, 44302501, 44302553, 44303217, 44303221, 44303257, 44303279, 44303282, 44303307, 44303343, 44303346, 44303351, 44303387, 44303395, 44303434, 44303444, 44303451, 44303539, 44303549, 44312723, 44312861, 44312904, 44312953, 44312984, 44314237, 44314304, 44314413, 44314449, 44314489, 44314568, 44315108, 44315183, 44315260, 44315317, 44315364, 44315398, 44315479, 44315621, 44315715, 44315888, 44315923, 44316252, 44316311, 44316511, 44316569, 44316692, 44316835, 44318589, 44318739, 44326616, 44326685, 44326708, 44326769, 44326834, 44326943, 44327225, 44327323, 44327409, 44327514, 44327546, 44327568, 44327592, 44327700, 44327764, 44328014, 44328038, 44328127, 44328164, 44328314, 44328343, 44328391, 44328431, 44328486, 44328514, 44328551, 44330212, 44330257, 44330279, 44330369, 44330482, 44330512, 44330586, 44330700, 44330725, 44330829, 44330897, 44330971, 44331026, 44331123, 44331188, 44331275, 44331441, 44331518, 44331557, 44331632, 44331823, 44331903, 44331919, 44332204, 44332252, 44332954, 44333020, 44333090, 44333205, 44333272, 44334882, 44334886, 44334938, 44335092, 44335206, 44335366, 44335640, 44335698, 44335740, 44335807, 44336138, 44336176, 44336364, 44336378, 44336872, 44336884, 44336975, 44337040, 44337099, 44337163, 44337197, 44337233, 44337276, 44337415, 44337490, 44337537, 44337806, 44339313, 44339341, 44339362, 44339381, 44339419, 44339425, 44339475, 44339505, 44339598, 44339655, 44339696, 44339765, 44339800, 44339826, 44339830, 44339860, 44339866, 44340011, 44340151, 44340245, 44340252, 44340335, 44340347, 44340394, 44340422, 44340441, 44340493, 44340504, 44340509, 44340546, 44340552, 44340592, 44340649, 44340710, 44340846, 44341040, 44341196, 44341231, 44341387, 44341433, 44341493, 44341505, 44341531, 44341552, 44341561, 44341710, 44341755, 44341781, 44341921, 44341977, 44342010, 44342060, 44342141, 44342200, 44342402, 44342701, 44342716, 44349815, 44349890, 44349983, 44350131, 44350171, 44350171, 44350206, 44350230, 44350490, 44350526, 44350563, 44350599, 44350666, 44350879, 44351050, 44351154, 44351197, 44351589, 44354347, 44354377, 44354400, 44354583, 44354674, 44354829, 44354859, 44354963, 44356845, 44356865, 44356913, 44356944, 44357015, 44357018, 44357276, 44358826, 44358830, 44358849, 44358855, 44358860, 44358864, 44358872, 44358902, 44358905, 44358944, 44358969, 44359026, 44359101, 44359140, 44359168, 44360003, 44360132, 44360181, 44360200, 44360258, 44360311, 44361060, 44361121, 44361245, 44361264, 44361330, 44361362, 44361405, 44361418, 44361459, 44361503, 44361533, 44361561, 44361568, 44361594, 44361608, 44361631, 44361636, 44361673, 44361779, 44361811, 44361933, 44361942, 44361978, 44362000, 44362064, 44362249, 44362261, 44362397, 44362422, 44362427, 44362471, 44362474, 44370990, 44371002, 44371014, 44371030, 44371033, 44371071, 44371164, 44371220, 44371244, 44371324, 44371354, 44371385, 44371400, 44371435, 44371466, 44371517, 44371672, 44371698, 44371723, 44371729, 44371808, 44371828, 44371847, 44371895, 44371907, 44371971, 44371976, 44372023, 44372141, 44372148, 44372168, 44372184, 44372192, 44372287, 44372293, 44372333, 44372343, 44372387, 44372427, 44372448, 44372481, 44372495, 44372661, 44372699, 44372704, 44372713, 44372753, 44372782, 44372794, 44372823, 44372988, 44372995, 44373044, 44373048, 44373242, 44373561, 44373569, 44373676, 44373677, 44373780, 44373783, 44373831, 44373838, 44373850, 44373864, 44373889, 44373890, 44373915, 44373934, 44373981, 44374006, 44376127, 44376132, 44376156, 44376168, 44376203, 44376257, 44376258, 44376743, 44376760, 44376858, 44376921, 44377036, 44377042, 44377072, 44377091, 44377117, 44377129, 44377144, 44377172, 44377179, 44377340, 44377364, 44377367, 44377368, 44377479, 44377500, 44377552, 44377620, 44377625, 44377648, 44377675, 44377727, 44377775, 44377788, 44377862, 44377864, 44377889, 44377954, 44377997, 44378007, 44378008, 44378064, 44378155, 44399813, 44399985, 44400215, 44400219, 44400258, 44400279, 44400312, 44400323, 44400343, 44400371, 44400377, 44400412, 44400415, 44400486, 44400499, 44400548, 44400738, 44400792, 44400843, 44400844, 44400879, 44400906, 44400913, 44400959, 44400966, 44400984, 44401008, 44401009, 44401025, 44401043, 44401133, 44401174, 44401229, 44401256, 44401333, 44401423, 44401444, 44401548, 44401572, 44401577, 44401609, 44401651, 44401692, 44401705, 44401714, 44401973, 44401976, 44402019, 44402021, 44406172, 44406173, 44406194, 44406195, 44406218, 44406260, 44406367, 44406377, 44406385, 44406481, 44406489, 44406545, 44406571, 44406607, 44406608, 44406631, 44406654, 44406655, 44406686, 44406688, 44406707, 44406708, 44406771, 44406792, 44406833, 44406862, 44406981, 44406994, 44407074, 44407127, 44407199, 44407210, 44407263, 44407273, 44407302, 44407311, 44407361, 44407403, 44407458, 44407464, 44407509, 44407527, 44407543, 44407574, 44407614, 44407649, 44407670, 44407721, 44407765, 44407837, 44407844, 44408363, 44408395, 44408408, 44408427, 44408438, 44408484, 44408498, 44408501, 44408529, 44408615, 44408649, 44408680, 44408680, 44408683, 44408697, 44408745, 44408805, 44409118, 44409171, 44409180, 44409188, 44409196, 44409221, 44409224, 44409248, 44409265, 44409277, 44409300, 44409390, 44409447, 44409453, 44409506, 44409521, 44411152, 44411200, 44411227, 44411238, 44411284, 44411295, 44411436, 44411477, 44411505, 44411578, 44411595, 44411676, 44411736, 44411753, 44411770, 44411859, 44411905, 44411907, 44411946, 44411948, 44412059, 44412095, 44412122, 44412172, 44412233, 44412247, 44412250, 44412295, 44412297, 44412308, 44412364, 44412397, 44412428, 44412468, 44412493, 44412501, 44412548, 44412575, 44412635, 44412702, 44412757, 44412809, 44412918, 44413113, 44413114, 44413163, 44413181, 44413210, 44413225, 44413253, 44413278, 44413280, 44413320, 44413361, 44413366, 44413436, 44413516, 44413579, 44413625, 44413626, 44413751, 44413778, 44413789, 44413833, 44413852, 44413855, 44413912, 44413932, 44413944, 44413974, 44413986, 44414010, 44414053, 44415984, 44415986, 44416002, 44416009, 44416059, 44416131, 44416144, 44416172, 44416182, 44416195, 44416217, 44416266, 44416302, 44416318, 44416463, 44416522, 44416548, 44416667, 44416680, 44416724, 44416729, 44416784, 44416790, 44416837, 44416865, 44416943, 44416971, 44417034, 44417116, 44417122, 44417202, 44417258, 44417265, 44417696, 44425639, 44425667, 44425681, 44425693, 44425725, 44425744, 44425827, 44425892, 44425954, 44426078, 44426708, 44426729, 44426790, 44428205, 44429766, 44429773, 44429829, 44429962, 44430765, 44430804, 44430872, 44431005, 44431113, 44433407, 44433432, 44433517, 44433567, 44433686, 44433695, 44433811, 44433825, 44433851, 44434001, 44434103, 44434130, 44434140, 44434190, 44434208, 44434344, 44434359, 44434460, 44434597, 44434641, 44434712, 44434716, 44434897, 44434930, 44435058, 44435086, 44435121, 44435134, 44435246, 44435362, 44435363, 44435437, 44435441, 44435734, 44435757, 44435825, 44435837, 44435881, 44435914, 44435936, 44436008, 44436010, 44436045, 44436069, 44436201, 44436208, 44436227, 44436295, 44436325, 44436336, 44436360, 44436490, 44436514, 44436542, 44436552, 44436586, 44436599, 44436635, 44436729, 44436776, 44436789, 44436817, 44438406, 44438416, 44438430, 44438439, 44438482, 44438500, 44438567, 44438598, 44438675, 44438691, 44438709, 44438728, 44438733, 44438772, 44438817, 44438850, 44438987, 44439028, 44439068, 44439111, 44439167, 44439169, 44439224, 44439238, 44439255, 44439282, 44439365, 44439366, 44439421, 44439440, 44439468, 44439473, 44439560, 44439570, 44439623, 44439661, 44439734, 44439878, 44439898, 44440152, 44440160, 44440210, 44440247, 44440252, 44440286, 44440320, 44440356, 44440388, 44440416, 44440453, 44440490, 44440552, 44440582, 44440594, 44440604, 44440652, 44440680, 44440697, 44440811, 44440835, 44440886, 44440902, 44440958, 44441024, 44441216, 44441240, 44441329, 44441358, 44441392, 44447915, 44447920, 44447925, 44447949, 44447974, 44447978, 44448053, 44448073, 44448077, 44448129, 44448135, 44448166, 44448167, 44448194, 44448199, 44448327, 44448336, 44448354, 44448428, 44448440, 44448466, 44448468, 44448505, 44448506, 44448534, 44448535, 44448568, 44448581, 44448612, 44448626, 44448650, 44448691, 44448702, 44448739, 44448759, 44448796, 44448930, 44449001, 44449010, 44449021, 44449089, 44449155, 44449213, 44449227, 44449416, 44449446, 44449463, 44449478, 44449647, 44449664, 44449679, 44449717, 44449744, 44449825, 44449909, 44449926, 44450019, 44450038, 44450040, 44450073, 44450095, 44450149, 44450159, 44450259, 44450261, 44450464, 44450484, 44450507, 44450533, 44450533, 44451617, 44451662, 44451723, 44451910, 44452034, 44452092, 44452220, 44452383, 44452522, 44452559, 44457613, 44457657, 44457690, 44457744, 44457758, 44457762, 44457786, 44457797, 44457820, 44457821, 44457852, 44457872, 44457943, 44457953, 44457976, 44458064, 44458082, 44458093, 44458104, 44458150, 44458160, 44458187, 44458233, 44458245, 44458286, 44458293, 44458340, 44458347, 44458413, 44458445, 44459865, 44459867, 44459882, 44459893, 44459900, 44459904, 44459944, 44460016, 44460098, 44460100, 44460124, 44460159, 44460174, 44460188, 44460194, 44460214, 44460218, 44460332, 44460356, 44460679, 44460749, 44460796, 44460843, 44460915, 44461040, 44461131, 44461805, 44461936, 44461948, 44461967, 44461970, 44462045, 44462093, 44462113, 44462223, 44462279, 44462280, 44462344, 44462816, 44463095, 44463122, 44463132, 44463182, 44463190, 44463216, 44463281, 44463297, 44463354, 44463385, 44463394, 44463440, 44463466, 44463515, 44463537, 44463605, 44463608, 44463636, 44463700, 44463712, 44463715, 44463726, 44463738, 44463753, 44463773, 44463798, 44463821, 44463849, 44463853, 44463915, 44463947, 44463987, 44463993, 44464474, 44464492, 44464501, 44464593, 44464624, 44464734, 44464751, 44472853, 44490118, 44496184, 44496197, 44496221, 44496226, 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  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. || Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
  • Manufacturer
  • 1 Event

Manufacturer

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