AED Recalls

Alert Details for #2007090301   (Released 9/25/2007 9:18 EDT)
Description: Update to RASMAS alert #2007090276 of 9/20/07 (Serial Numbers Specified) Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator 
Manufacturer: Welch Allyn Protocol, Inc., Beaverton, OR 
Reason: 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. 
Analyst Comments: Please click on the hyperlink and the attachment to view notification details dated August 23, 2007. 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. For additional information, contact Robert Berry at 503-530-7935. Contact Welch Allyn at Tel: 1-800-462-0777, Tel: 503-530-7500, or Fax: 503-530-5650. 

Alert Type: Recall URGENT Source Alert Type: FDA CLASS I
Domain: Biomedical Devices Source Type: Food and Drug Administration
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. Source Date: 9/25/2007

Links:
FDA CDRH Website - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=55297
Welch Allyn Website - http://www.monitoring.welchallyn.com/
FDA CDRH Notification (pdf) - AED2007090301.pdf

Product Information
Product Description Model/Product Number Stock Identifiers Volume Recall ID
Welch Allyn AED 20 Automated External Defibrillator; a protable, 12V internal battery powered defibrillator  Model AED 20, Catalog Numbers: 972213, 972214, 972215, 972216 (Part Numbers: 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)  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.   1,637 devices total.   Z-1223-2007