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|
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 |
| 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 |
|
