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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK EXPRESS AED

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  Class 2 Device Recall LIFEPAK EXPRESS AED see related information
Date Initiated by Firm October 05, 2006
Date Posted June 21, 2007
Recall Status1 Terminated 3 on August 08, 2013
Recall Number Z-0837-2007
Recall Event ID 36484
510(K)Number K011144  
Product Classification Defibrillator (AED) - Product Code MKJ
Product LIFEPAK EXPRESS defibrillator
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact James T. (Todd) Bandy
425-867-4514
Manufacturer Reason
for Recall		 Premature battery depletion due to electrical component failure
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.
Quantity in Commerce Total of Express 1,006 units worldwide; amount does not include units distributed to Japan.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.
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