RecallDepth

Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E

Company
Mrl, Inc., A Welch Allyn Company
Recall Initiated
April 28, 2005
Posted
May 12, 2005
Terminated
September 1, 2006
Recall Number
Z-0806-05
Quantity
597
Firm Location
Buffalo Grove, IL

Reason for Recall

The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.

Distribution

Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.

Lot / Code Info

Serial numbers 201887, 204213, 205309, 205857, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 206073, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206094, 206096, 206097, 206098, 206101, 206111, 206112, 206113, 206114, 206115, 206116, 206117, 206118, 206119, 206120, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206146, 206147, 206149, 206150, 206151, 206152, 206153, 206154, 206159, 206160, 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, 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, 206262, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206284, 206285, 206286, 206287, 206289, 206290, 206291, 206292, 206293, 206294, 206295, 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, 206326, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 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, 206372, 206373, 206374, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206408, 206409, 206410, 206411, 206412, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435,  206436, 206438, 206439, 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, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206487, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206495, 206496, 206497, 206498, 206499, 206500, 206501, 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, 206548, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206559, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206568, 206569, 206570, 206571, 206572, 206573, 206574, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206597, 206598, 206599, 206600, 206601, 206602, 206603, 206604, 206605, 206606, 206607.206608, 206609, 206610, 206611, 206612, 206613, 206614, 206615, 206616, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206640, 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, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206702, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711

Root Cause

Device Design

Action Taken

Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

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