Medtronic Emergency Response Systems, Inc.

20 devices in the database

  • Model / Serial
    Serial Numbers are for units with lead free capacitor C177. The following list of Serial Numbers does not include units sent to Japan, as firm does not consider them to be part of its Safety Alert action.   Serial Numbers: 34344155, 34176900, 34176892, 34176894, 34176896, 34176899, 34335036, 34335035, 34352271, 34335029, 33954274, 33954276, 33954277, 33954279, 33954280, 33954282, 34303575, 34151174, 34285509, 34285510, 34285511, 34285512, 34285513, 34285514, 34285515, 34285516, 34046893, 34046894, 34046895, 34046896, 34250191, 34014954, 34018318, 34056524, 34104971, 34684122, 34046902, 34046903, 34298409, 34298410, 34298411, 34298412, 34298413, 34298414, 34298415, 34298416, 34298417, 34298418, 34298419, 34298420, 34298421, 34014928, 34014930, 34014931, 34046905, 34014963, 34014964, 34014965, 34014966, 34014967, 34011973, 33954246, 34014933, 34014936, 34350472, 34285528, 34304529, 34229704, 34229705, 34229706, 34250885, 34250891, 34250893, 34018321, 34350460, 34018307, 34018301, 34303983, 34285547, 34018305, 34018303, 34303980, 34032552, 34303977, 34091673, 34049712, 34051058, 34051084, 34051085, 34252107, 34051091, 34252072, 34056817, 34251936, 34252111, 34022894, 34022895, 34022896, 34022897, 34022898, 34022899, 34022900, 34022901, 34022902, 34022903, 34022904, 34022905, 34022906, 34022907, 34022908, 34022909, 34022910, 34022911, 34022912, 34022913, 34022914, 34022915, 34022916, 34022917, 34022918, 34022919, 34022920, 34022921, 34022922, 34022923, 34022924, 34022925, 34022926, 34022927, 34022928, 34022929, 34022930, 34022931, 34022932, 34022933, 34022934, 34022935, 34022936, 34022937, 34022938, 34022939, 34022940, 34022941, 34022942, 34022943, 34022944, 34022945, 34022946, 34022947, 34022948, 34022949, 34022950, 34022951, 34022952, 34022953, 34022954, 34022955, 34022957, 34022958, 34022959, 34022960, 34022961, 34022962, 34022963, 34022964, 34022965, 34022966, 34022967, 34022968, 34022969, 34022970, 34022971, 34022972, 34051026, 34051027, 34051029, 34051030, 34051031, 34051032, 34051033, 34051034, 34051035, 34051036, 34051037, 34051038, 34051039, 34051040, 34051041, 34051042, 34051043, 34051044, 34051045, 34051046, 34051048, 34051049, 34051050, 34051051, 34051052, 34051053, 34051054, 34051055, 34051056, 34051057, 34051059, 34051060, 34051061, 34051062, 34051063, 34051064, 34051065, 34051066, 34051067, 34051068, 34051069, 34051070, 34051071, 34051072, 34051073, 34051074, 34051075, 34051076, 34051077, 34051078, 34051079, 34051080, 34051081, 34051083, 34051086, 34051087, 34051088, 34051089, 34051090, 34051092, 34051093, 34051094, 34051095, 34051096, 34051097, 34051098, 34051099, 34051100, 34051101, 34051102, 34051104, 34051105, 34053120, 34309063, 34309064, 34309065, 34309066, 34309067, 34309068, 34309069, 34309071, 34309072, 34309073, 34309074, 34309075, 34309076, 34309077, 34309093, 34309094, 34309097, 34309098, 34309099, 34309100, 34309101, 34309102, 34309103, 34309104, 34309105, 34309106, 34309107, 34309109, 34309110, 34309111, 34309112, 34309113, 34309114, 34309116, 34309117, 34309118, 34309120, 34309121, 34309122, 34309123, 34309124, 34309125, 34309126, 34309127, 34309128, 34309168, 34309172, 34309176, 34309178, 34309181, 34309187, 34309189, 34309193, 34309195, 34309197, 34309201, 34309202, 34309204, 34309206, 34309207, 34309209, 34309211, 34309212, 34309214, 34309216, 34309217, 34309219, 34309220, 34309222, 34309223, 34309225, 34309233, 34309235, 34309236, 34309238, 34309240, 34309190, 34252101, 34285554, 34285555, 34285556, 34285557, 34285558, 34285559, 34309192, 34252115, 34352277, 34352278, 34352279, 34051103, 34217097, 34467124, 34467125, 34467126, 34482065, 34067612, 34330527, 34330528, 34330531, 34330532, 34330533, 34330534, 34330535, 34330538, 34330539, 34330540, 34330542, 34330543, 34330544, 34330546, 34330568, 34330572, 34047159, 34047160, 34047161, 34047162, 34047163, 34047164, 34047165, 34047166, 34047167, 34047168, 34047169, 34047170, 34047171, 34047172, 34047173, 34047174, 34047175, 34047176, 34047177, 34047178, 34047179, 34047180, 34047181, 34047182, 34047183, 34047184, 34047185, 34047186, 34047187, 34047188, 34047189, 34047190, 34047191, 34047192, 34047193, 34047195, 34047196, 34047197, 34043693, 33923349, 33923350, 33923352, 33923353, 33923357, 34066260, 34234400, 34234401, 34234402, 34234403, 34234404, 33928259, 34476797, 34682138, 34352630, 34230262, 34230263, 34230264, 34230265, 34230266, 34230267, 34230268, 34230269, 34046385, 34056336, 34056762, 34085482, 34085483, 34300513, 34050928, 34050930, 34050932, 34056342, 34056343, 34069952, 34087890, 34352568, 34056360, 34056361, 34056771, 34300481, 34300482, 34051082, 34056339, 34144650, 34144651, 34034052, 34085487, 34235978, 34462172, 34104969, 34208309, 34208310, 34208313, 34309256, 34104970, 33928020, 34309247, 34250207, 34250197, 34250204, 34250208, 34250195, 34250205, 34037755, 34037756, 34352738, 34250206, 34250209, 34250196, 34018313, 34018315, 34350433, 34056526, 34056527, 34056529, 34056772, 34309242, 34309243, 34309246, 34309248, 34309260, 34309264, 34330600, 34328806, 34328807, 34303805, 34316106, 34316120, 34255361, 33924004, 34018329, 34059342, 34335256, 34335257, 34335260, 34335264, 34225876, 33934824, 33934835, 34285563, 34309244, 34476272, 33934833, 34330121, 34120198, 34120199, 34120200, 34120202, 34120203, 34120204, 34120205, 34120206, 34120207, 34120208, 34120209, 34120210, 34120211, 34120212, 34066777, 34250905, 34250906, 34250907, 34250908, 34250909, 34250910, 34250911, 34250912, 34250913, 34250914, 34250915, 34096281, 34032829, 34066778, 34066779, 34066780, 34482253, 34222370, 34309245, 33955700, 34309257, 34056528, 34056525, 34056522, 34018332, 34056521, 34087747, 34251926, 34018310, 34208330, 33974362, 33974357, 33974358, 33974359, 33974360, 33974361, 33974363, 34684113, 34069936, 34069937, 34056802, 34056803, 34085478, 34085479, 34086761, 34086762, 34086763, 34086764, 34086765, 34303967, 34309249, 34056705, 34056706, 34056707, 34056708, 34056709, 34124843, 34217071, 34230247, 34037736, 34062533, 34249908, 34249909, 34285530, 34335281, 34335282, 34335283, 34335285, 34335286, 34335287, 34335291, 34335293, 34335294, 34335295, 34018335, 34014941, 34350499, 34209430, 34209433, 34039298, 34018323, 34267821, 34267823, 34267824, 34267825, 34267827, 34267829, 34267830, 34267831, 34267832, 34267833, 34267834, 34267835, 34267836, 34267837, 34267839, 34267840, 34267841, 34267842, 34267843, 34267828, 34229708, 34459857, 34176902, 34327649, 34309262, 34466935, 34327631, 34264717, 34264718, 34264719, 34264730, 34264731, 34264724, 34264725, 34264726, 34264727, 34018450, 34327645, 34330949, 34044786, 34044790, 34044792, 34264630, 34264631, 34264632, 34264633, 34314929, 34314930, 34039310, 34039311, 34039312, 34039313, 34039316, 34087355, 34087356, 34124846, 34264680, 34264682, 34264683, 34039314, 34039315, 34039318, 34039309, 34039317, 34018292, 34018296, 34018299, 34264664, 34264665, 34264666, 34264667, 34264668, 34264669, 34264670, 34264671, 34264672, 34264673, 34018448, 34004030, 34460685, 34481138, 34482528, 34094315, 34094316, 34094317, 34094318, 34094319, 34094320, 34094321, 34094322, 34094323, 34094324, 34094325, 34094326, 34345445, 34345440, 34478433, 34003998, 34003999, 34004000, 34004001, 34004002, 34046859, 34046860, 34046878, 34046874, 34047363, 34047364, 34047368, 34047375, 34047376, 34047377, 34285481, 34285482, 34285483, 34285506, 34003252, 34003253, 34003254, 34003255, 34003256, 34046876, 34002807, 34002808, 34002804, 34003052, 34003053, 34003054, 34003265, 34003266, 34003267, 34003268, 34003269, 34003270, 34003271, 34002956, 34285497, 34285499, 34285501, 34285503, 34285507, 34285508, 34285495, 34003981, 34003982, 34005490, 34285476, 34004344, 34047373, 34003277, 34003278, 34003279, 34014917, 34047365, 34047372, 34047342, 34047366, 34002806, 34285494, 34046885, 34046886, 34046887, 34004018, 34004019, 34004021, 34004022, 34004023, 34004024, 34004366, 34285500, 34004075, 34004337, 34004339, 34285505, 34046881, 34004120, 34047343, 34047369, 34285504, 34002789, 34002790, 34002792, 34002793, 34002794, 34002795, 34002796, 34002797, 34047339, 34047335, 34047374, 34004009, 34004010, 34002946, 34002947, 34002948, 34002949, 34002950, 34002951, 34002952, 34002953, 34046872, 34004364, 34047341, 34046864, 34047336, 34047338, 34047340, 34047344, 34002936, 34285496, 34004032, 34285502, 34047367, 34047371, 34047370, 34285484, 34285475, 34285493, 34285498, 34046870, 34285480, 34047337, 34046866, 34285478, 34285479, 34004192, 34004330, 34004331, 34004332, 34002805, 34264652, 34264653, 34264742, 34264743, 34264744, 34264745, 34264746, 34264747, 34281313, 34352070, 34018297, 34264734, 34264735, 34018294, 34044711, 34234275, 34009256, 34002662, 34044681, 34018290, 34018291, 34018293, 34018295, 34018298, 34343761, 34343772, 34343774, 34343775, 34343777, 34343790, 34343799, 34682300, 34264689, 34264690, 34264691, 34264692, 34264693, 34264699, 34264701, 34264702, 34264703, 34264707, 34264708, 34264709, 34333589, 34327647, 34144829, 34351843, 34351827, 34104972, 34069584, 34069585, 34069586, 34069587, 34069588, 34069589, 34069590, 34144830, 34144831, 34351850, 34144827, 34456426, 34482256, 34264712, 34264713, 34327629, 34482259, 34014938, 34328878, 34062568, 34062569, 34062570, 34285526, 34058294, 34309250, 34309252, 34337442, 34289601, 34290045, 34290147, 34290148, 34290149, 34290150, 34290151, 34290152, 34290153, 34290154, 34290155, 34290156, 34290157, 34290158, 34290159, 34290160, 34290161, 34290162, 34290163, 34290164, 34290165, 34290166, 34290167, 34290168, 34290169, 34290170, 34290171, 34290172, 34290173, 34290176, 34290177, 34290178, 34290180, 34290181, 34290182, 34290183, 34290184, 34290186, 34290187, 34290188, 34290189, 34290190, 34290191, 34290192, 34290193, 34290194, 34290195, 34290196, 34290197, 34290198, 34290199, 34290200, 34290201, 34290202, 34290204, 34290205, 34290209, 34290212, 34290217, 34290219, 34290225, 34290226, 34290228, 34290229, 34290230, 34290231, 34290232, 34290233, 34290234, 34290235, 34290236, 34290237, 34290238, 34290239, 34290243, 34290245, 34290246, 34290247, 34290248, 34290249, 34290251, 34290252, 34290253, 34290254, 34290255, 34290256, 34345858, 34345867, 34346123, 34318014, 34325153, 34325155, 34325156, 34325157, 34325158, 34325159, 34325296, 34325356, 34325357, 34325358, 34325359
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
  • Product Description
    LIFEPAK EXPRESS defibrillator
  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
  • Product Description
    LIFEPAK CR Plus defibrillator
  • Model / Serial
    Standard Hard Paddles part number: 3006228-013 and below
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed worldwide.
  • Product Description
    standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
  • Model / Serial
    Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed worldwide.
  • Product Description
    QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
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3 manufacturers with a similar name

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  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HMC