Devices

LIFEPAK 15 Monitor/Defibrillator

Fabricant

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHM

17 dispositifs médicaux avec un nom similaire

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Device Recall The LIFEPAK 15 monitor/defibrillator
  • Modèle / numéro de série
    This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    worldwide
  • Description du dispositif
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical || personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK 15 Monitor/Defibrillator
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
Device Recall The LIFEPAK 15 Monitor/Defibrillator (LP15)
  • Modèle / numéro de série
    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, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
    Physio-Control, Inc.
Lifepak 15 Monitor/Defibrillator
  • Modèle / numéro de série
  • Description du dispositif
    Medical electronics / Electromedical devices
  • Manufacturer
    Medtronic
Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Manufacturer
    Physio-Control
12 en plus