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Medical Device Recalls
Class 1 Recall
Welch Allyn AED 20 Defibrillator
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Date Recall Initiated |
August 23, 0007
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Date Posted |
September 19, 2007
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Recall Number |
Z-1223-2007
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Product |
Welch Allyn AED 20 Automated External Defibrillator; a protable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
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Code Information |
8, 207339, 207340, 207341, 207342, 207343, 207344, 207345, 207346, 207347, 207348, 207349, 207350, 207351, 207352, 207353, 207354, 207355, 207356, 207357, 207358, 207359, 207360, 207361, 207362, 207363, 207364, 207365, 207366, 207367, 207368, 207369, 207370, 207371, 207372, 207373, 207374, 207375, 207376, 207377, 207378, 207379, 207380, 207381, 207382, 207383, 207384, 207387, 207389, 207390, 207391, 207392, 207393, 207394, 207395, 207396, 207397, 207398, 207399, 207400, 207401, 207402, 207403, 207404, 207405, 207406, 207407, 207408, 207409, 207410, 207411, 207412, 207413, 207414, 207415, 207416, 207417, 207418, 207419, 207420, 207421, 207422, 207423, 207424, 207425, 207426, 207427, 207428, 207429, 207430, 207431, 207432, 207433, 207434, 207435, 207436, 207437, 207438, 207439, 207440, 207442, 207443, 207444, 207445, 207445, 207446, 207447, 207448, 207449, 207450, 207451, 207452, 207453, 207454, 207455, 207456, 207457, 207458, 207459, 207460, 207461, 207462, 207463, 207464, 207465, 207467, 207468, 207469, 207470, 207472, 207473, 207474, 207475, 207476, 207477, 207478, 207479, 207481, 207484, 207485, 207486, 207487, 207492, 207495. 7, 206818, 206819, 206820, 206821, 206822, 206823, 206824, 206825, 206826, 206827, 206828, 206829, 206830, 206831, 206832, 206833, 206834, 206835, 206836, 206837, 206838, 206839, 206840, 206841, 206842, 206843, 206844, 206845, 206846, 206847, 206848, 206849, 206850, 206851, 206852, 206853, 206854, 206855, 206856, 206858, 206860, 206861, 206862, 206863, 206864, 206867, 206868, 206869, 206870, 206871, 206872, 206873, 206874, 206875, 206876, 206877, 206878, 206879, 206880, 206881, 206882, 206883, 206884, 206885, 206886, 206887, 206888, 206889, 206890, 206891, 206892, 206893, 206894, 206895, 206896, 206897, 206898, 206899, 206900, 206901, 206902, 206903, 206904, 206905, 206906, 206907, 206908, 206909, 206910, 206911, 206912, 206913, 206914, 206915, 206916, 206917, 206918, 206919, 206920, 206921, 206922, 206923, 206924, 206925, 206926, 206927, 206928, 206929, 206930, 206931, 206932, 206933, 206934, 206935, 206936, 206937, 206938, 206939, 206940, 206941, 206942, 206943, 206944, 206945, 206946, 206947, 206948, 206949, 206950, 206951, 206952, 206953, 206954, 206955, 206956, 206957, 206958, 206959, 206960, 206961, 206962, 206963, 206964, 206965, 206966, 206967, 206969, 206970, 206971, 206972, 206973, 206974, 206975, 206976, 206977, 206978, 206979, 206980, 206981, 206982, 206983, 206984, 206985, 206986, 206987, 206988, 206989, 206990, 206991, 206992, 206993, 206994, 206995, 206996, 206997, 206998, 206999, 207000, 207001, 207002, 207003, 207004, 207005, 207006, 207007, 207008, 207009, 207010, 207011, 207012, 207013, 207015, 207016, 207017, 207018, 207020, 207022, 207023, 207024, 207026, 207027, 207028, 207029, 207030, 207031, 207032, 207033, 207034, 207035, 207036, 207037, 207039, 207040, 207041, 207042, 207043, 207044, 207045, 207046, 207047, 207048, 207049, 207050, 207051, 207052, 207053, 207054, 207055, 207056, 207057, 207058, 207059, 207060, 207061, 207062, 207063, 207064, 207065, 207066, 207067, 207068, 207069, 207070, 207071, 207072, 207073, 207074, 207075, 207076, 207077, 207078, 207079, 207080, 207081, 207082, 207083, 207084, 207085, 207086, 207087, 207088, 207089, 207090, 207091, 207092, 207093, 207094, 207095, 207096, 207097, 207098, 207099, 207100, 207101, 207102, 207103, 207104, 207105, 207106, 207107, 207108, 207110, 207111, 207112, 207113, 207114, 207115, 207116, 207117, 207118, 207119, 207120, 207121, 207122, 207123, 207124, 207125, 207126, 207127, 207128, 207129, 207130, 207131, 207132, 207133, 207134, 207135, 207137, 207138, 207139, 207140, 207141, 207142, 207143, 207144, 207145, 207146, 207147, 207148, 207149, 207150, 207151, 207152, 207153, 207154, 207155, 207156, 207157, 207158, 207159, 207160, 207161, 207162, 207164, 207165, 207166, 207169, 207171, 207172, 207173, 207174, 207175, 207176, 207177, 207178, 207179, 207180, 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207188, 207189, 207190, 207191, 207192, 207194, 207195, 207196, 207197, 207198, 207199, 207200, 207201, 207202, 207203, 207204, 207205, 207206, 207207, 207208, 207210, 207211, 207212, 207213, 207214, 207215, 207216, 207217, 207218, 207219, 207220, 207221, 207222, 207223, 207224, 207225, 207226, 207227, 207228, 207229, 207230, 207231, 207232, 207233, 207234, 207235, 207237, 207238, 207239, 207240, 207241, 207242, 207243, 207244, 207245, 207246, 207247, 207248, 207249, 207250, 207251, 207252, 207253, 207254, 207255, 207256, 207257, 207258, 207259, 207260, 207261, 207262, 207263, 207264, 207265, 207266, 207267, 207268, 207270, 207271, 207272, 207273, 207274, 207275, 207276, 207277, 207278, 207279, 207280, 207282, 207283, 207284, 207285, 207286, 207287, 207288, 207289, 207290, 207291, 207292, 207293, 207294, 207295, 207296, 207297, 207298, 207299, 207300, 207301, 207302, 207303, 207304, 207305, 207306, 207307, 207308, 207309, 207310, 207311, 207312, 207313, 207314, 207315, 207316, 207317, 207318, 207319, 207320, 207321, 207322, 207323, 207324, 207325, 207326, 207327, 207328, 207329, 207330, 207331, 207332, 207333, 207334, 207335, 207336, 207337, 20733Serial number range - 205787 - 207495 (non-contiguous)
205787, 205788, 205789, 205790, 205791, 205793, 205794, 205795, 205796, 205797, 205798, 205799, 205800, 205801, 205802, 205803, 205804, 205805, 205807, 205808, 205809, 205810, 205811, 205812, 205813, 205814, 205815, 205816, 205817, 205818, 205819, 205820, 205821, 205822, 205823, 205824, 205825, 205826, 205827, 205828, 205829, 205830, 205831, 205832, 205833, 205834, 205835, 205836, 205837, 205838, 205839, 205840, 205841, 205842, 205843, 205844, 205845, 205846, 205847, 205848, 205849, 205850, 205851, 205852, 205853, 205854, 205855, 205856, 205857, 205858, 205860, 205861, 205862, 205863, 205864, 205865, 205866, 205867, 205868, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 205879, 205880, 205881, 205882, 205883, 205884, 205885, 205886, 205887, 205888, 205889, 205890, 205891, 205892, 205893, 205894, 205897, 205898, 205899, 205900, 205901, 205902, 205903, 205904, 205905, 205906, 205908, 205909, 205910, 205911, 205912, 205913, 205914, 205915, 205916, 205917, 205918, 205919, 205920, 205921, 205922, 205923, 205924, 205925, 205926, 205927, 205928, 205929, 205930, 205931, 205932, 205933, 205934, 205935, 205936, 205937, 205938, 205939, 205940, 205941, 205942, 205943, 205944, 205945, 205946, 205947, 205948, 205949, 205950, 205951, 205952, 205953, 205954, 205956, 205957, 205958, 205959, 205960, 205961, 205962, 205963, 205964, 205965, 205966, 205967, 205968, 205969, 205970, 205971, 205972, 205973, 205974, 205975, 205976, 205977, 205978, 205979, 205980, 205981, 205982, 205983, 205984, 205985, 205986, 205987, 205988, 205989, 205990, 205991, 205992, 205994, 205995, 205996, 205997, 205998, 205999, 206000, 206001, 206002, 206003, 206004, 206005, 206006, 206007, 206008, 206009, 206010, 206011, 206012, 206013, 206014, 206015, 206016, 206017, 206018, 206019, 206020, 206021, 206022, 206023, 206024, 206025, 206026, 206027, 206028, 206029, 206030, 206032, 206033, 206034, 206035, 206036, 206037, 206038, 206039, 206040, 206041, 206042, 206043, 206044, 206045, 206046, 206047, 206048, 206049, 206050, 206051, 206052, 206053, 206054, 206055, 206056, 206057, 206059, 206060, 206061, 206062, 206063, 206064, 206065, 206066, 206067, 206068, 206069, 206070, 206071, 206072, 206074, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206082, 206083, 206084, 206085, 206086, 206087, 206088, 206089, 206090, 206091, 206092, 206093, 206094, 206095, 206096, 206097, 206098, 206099, 206100, 206101, 206102, 206103, 206104, 206105, 206106, 206107, 206108, 206109, 206110, 206111, 206112, 206113, 206114, 206115, 206116, 206118, 206119, 206120, 206121, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206134, 206135, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206147, 206148, 206149, 206150, 206151, 206152, 206153, 206154, 206155, 206156, 206157, 206158, 206159, 206160, 206161, 206162, 206163, 206164, 206165, 206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176, 206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186, 206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196, 206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206, 206207, 206208, 206209, 206210, 206211, 206212, 206213, 206214, 206215, 206216, 206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226, 206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236, 206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246, 206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256, 206257, 206258, 206259, 206260, 206261, 206263, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206283, 206284, 206285, 206286, 206287, 206288, 206289, 206290, 206291, 206292, 206293, 206294, 206296, 206297, 206298, 206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308, 206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318, 206319, 206320, 206321, 206322, 206323, 206324, 206325, 206326, 206327, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 206341, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349, 206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359, 206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369, 206370, 206371, 206372, 206373, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206389, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206410, 206411, 206412, 206413, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435, 206436, 206437, 206438, 206439, 206440, 206441, 206442, 206443, 206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453, 206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463, 206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473, 206474, 206475, 206476, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206496, 206497, 206498, 206499, 206500, 206501, 206502, 206503, 206504, 206505, 206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515, 206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525, 206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535, 206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545, 206546, 206547, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206569, 206571, 206572, 206575, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206596, 206597, 206598, 206599, 206600, 206602, 206603, 206604, 206605, 206606, 206607, 206608, 206609, 206610, 206611, 206612, 206613, 206614, 206617, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206631, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206692, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711, 206712, 206713, 206715, 206716, 206717, 206718, 206719, 206720, 206721, 206722, 206724, 206725, 206726, 206727, 206728, 206729, 206730, 206731, 206732, 206733, 206734, 206735, 206736, 206737, 206738, 206739, 206740, 206741, 206742, 206743, 206744, 206745, 206746, 206747, 206748, 206749, 206750, 206751, 206752, 206753, 206754, 206755, 206756, 206757, 206758, 206759, 206760, 206761, 206762, 206763, 206764, 206765, 206766, 206768, 206769, 206770, 206771, 206772, 206773, 206775, 206776, 206777, 206778, 206779, 206780, 206781, 206782, 206783, 206784, 206785, 206786, 206787, 206788, 206789, 206790, 206791, 206792, 206793, 206794, 206795, 206796, 206797, 206798, 206799, 206800, 206801, 206802, 206803, 206804, 206805, 206806, 206807, 206808, 206809, 206810, 206811, 206812, 206813, 206814, 206815, 206816, 20681
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Recalling Firm/ Manufacturer |
Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton
, Oregon
97008
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For Addition Information Contact |
Robert Berry
503-530-7935
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Reason For Recall |
Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
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Action |
On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to those customers.
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Quantity in Commerce |
1,637 devices
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Distribution |
Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.
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