Cardiac Science Corporation GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator
Brand
Cardiac Science Corporation
Lot Codes / Batch Numbers
Serial numbers: 384996, 4016037, 4016041, 4016048, 4016051, 4016052, 4016056, 4016058, 4016061, 4016064, 4016066, 4016068, 4016069, 4016081, 4016082, 4016083, 4016089, 4016093, 4016098, 4016100, 4016101, 4016110, 4016114, 4016122, 4016123, 4016125, 4016131, 4027309, 4027310, 4027311, 4027312, 4027313, 4027314, 4027315, 4027316, 4027317, 4027318, 4027319, 4027320, 4027321, 4027322, 4027323, 4027324, 4027325, 4027326, 4027327, 4027328, 4027329, 4027330, 4027331, 4027332, 4027333, 4027334, 4027335, 4027336, 4027337, 4027338, 4027339, 4027340, 4027341, 4027342, 4027343, 4027344, 4027345, 4027346, 4027347, 4027348, 4027349, 4027350, 4027351, 4027352, 4027353, 4027354, 4027355, 4027356, 4027357, 4027358, 4027359, 4027360, 4027361, 4027362, 4027363, 4027364, 4027365, 4027366, 4027367, 4027368, 4027369, 4027370, 4027371, 4027373, 4027374, 4027375, 4027376, 4027377, 4027378, 4027379, 4027380, 4027381, 4027382, 4027383, 4027384, 4027385, 4027386, 4027387, 4027388, 4027389, 4027390, 4027391, 4027392, 4027393, 4027394, 4027395, 4027396, 4027397, 4027398, 4027399, 4027400, 4027401, 4027402, 4027403, 4027404, 4027405, 4027406, 4027407, 4027408, 4038453, 4038454, 4038455, 4038456, 4038457, 4038458, 4038459, 4038460, 4038461, 4038462, 4038463, 4038464, 4038465, 4038466, 4038467, 4038468, 4038469, 4038470, 4038471, 4038472, 4038473, 4038474, 4038475, 4038476, 4038477, 4038478, 4038479, 4038480, 4038481, 4038482, 4038483, 4038484, 4038485, 4038486, 4038487, 4038488, 4038489, 4038490, 4038491, 4038492, 4038493, 4038494, 4038495, 4038496, 4038497, 4038498, 4038499, 4038500, 4038501, 4038502, 4038503, 4038504, 4038505, 4038506, 4038507, 4038508, 4038509, 4038510, 4038511, 4038512, 4038513, 4038515, 4038516, 4038517, 4038518, 4038519, 4038520, 4038522, 4038523, 4038524, 4038525, 4038527, 4038528, 4038529, 4038530, 4038531, 4038532, 4038533, 4038534, 4038535, 4038536, 4038537, 4038538, 4038539, 4038540, 4038541, 4038542, 4038543, 4038544, 4038545, 4038546, 4038547, 4038548, 4038549, 4038550, 4038551, 4038552, 4038553, 4038554, 4038555, 4038556, 4038557, 4038558, 4038559, 4038560, 4038561, 4038562, 4038563, 4038564, 4038565, 4038566, 4038567, 4038568, 4038569, 4038570, 4038571, 4038572, 4038573, 4038574, 4038575, 4038576, 4038577, 4038578, 4038579, 4038580, 4038581, 4038582, 4038583, 4038584, 4038585, 4038586, 4038587, 4038588, 4038589, 4038590, 4038591, 4038592, 4038593, 4038594, 4038595, 4038596, 4038597, 4038598, 4038599, 4038600, 4038601, 4038602, 4038603, 4038604, 4038605, 4038606, 4038607, 4038608, 4038609, 4038610, 4038611, 4038612, 4038613, 4038614, 4038615, 4038616, 4038617, 4038618, 4038619, 4038620, 4038621, 4038622, 4038623, 4038624, 4038625, 4038626, 4038627, 4038628, 4038629, 4038630, 4038631, 4038632, 4038633, 4038634, 4038635, 4038636, 4038637, 4038638, 4038639, 4038640, 4038641, 4038642, 4038643, 4038644, 4038645, 4038646, 4038647, 4038648, 4038649, 4038650, 4038651, 4038652, 4038653, 4038654, 4038655, 4038656, 4038657, 4038658, 4038659, 4038660, 4038661, 4038662, 4038663, 4038664, 4038665, 4038666, 4038667, 4038668, 4038669, 4038670, 4038671, 4038672, 4038673, 4038674, 4038675, 4038676, 4038677, 4038678, 4038679, 4038680, 4038681, 4038682, 4038683, 4038684, 4038685, 4038686, 4038687, 4038688, 4038689, 4038690, 4038691, 4038692, 4038693, 4038694, 4038695, 4038696, 4038697, 4038698, 4038699, 4038700, 4038701, and 4038702.
Products Sold
Serial numbers: 384996, 4016037, 4016041, 4016048, 4016051, 4016052, 4016056, 4016058, 4016061, 4016064, 4016066, 4016068, 4016069, 4016081, 4016082, 4016083, 4016089, 4016093, 4016098, 4016100, 4016101, 4016110, 4016114, 4016122, 4016123, 4016125, 4016131, 4027309, 4027310, 4027311, 4027312, 4027313, 4027314, 4027315, 4027316, 4027317, 4027318, 4027319, 4027320, 4027321, 4027322, 4027323, 4027324, 4027325, 4027326, 4027327, 4027328, 4027329, 4027330, 4027331, 4027332, 4027333, 4027334, 4027335, 4027336, 4027337, 4027338, 4027339, 4027340, 4027341, 4027342, 4027343, 4027344, 4027345, 4027346, 4027347, 4027348, 4027349, 4027350, 4027351, 4027352, 4027353, 4027354, 4027355, 4027356, 4027357, 4027358, 4027359, 4027360, 4027361, 4027362, 4027363, 4027364, 4027365, 4027366, 4027367, 4027368, 4027369, 4027370, 4027371, 4027373, 4027374, 4027375, 4027376, 4027377, 4027378, 4027379, 4027380, 4027381, 4027382, 4027383, 4027384, 4027385, 4027386, 4027387, 4027388, 4027389, 4027390, 4027391, 4027392, 4027393, 4027394, 4027395, 4027396, 4027397, 4027398, 4027399, 4027400, 4027401, 4027402, 4027403, 4027404, 4027405, 4027406, 4027407, 4027408, 4038453, 4038454, 4038455, 4038456, 4038457, 4038458, 4038459, 4038460, 4038461, 4038462, 4038463, 4038464, 4038465, 4038466, 4038467, 4038468, 4038469, 4038470, 4038471, 4038472, 4038473, 4038474, 4038475, 4038476, 4038477, 4038478, 4038479, 4038480, 4038481, 4038482, 4038483, 4038484, 4038485, 4038486, 4038487, 4038488, 4038489, 4038490, 4038491, 4038492, 4038493, 4038494, 4038495, 4038496, 4038497, 4038498, 4038499, 4038500, 4038501, 4038502, 4038503, 4038504, 4038505, 4038506, 4038507, 4038508, 4038509, 4038510, 4038511, 4038512, 4038513, 4038515, 4038516, 4038517, 4038518, 4038519, 4038520, 4038522, 4038523, 4038524, 4038525, 4038527, 4038528, 4038529, 4038530, 4038531, 4038532, 4038533, 4038534, 4038535, 4038536, 4038537, 4038538, 4038539, 4038540, 4038541, 4038542, 4038543, 4038544, 4038545, 4038546, 4038547, 4038548, 4038549, 4038550, 4038551, 4038552, 4038553, 4038554, 4038555, 4038556, 4038557, 4038558, 4038559, 4038560, 4038561, 4038562, 4038563, 4038564, 4038565, 4038566, 4038567, 4038568, 4038569, 4038570, 4038571, 4038572, 4038573, 4038574, 4038575, 4038576, 4038577, 4038578, 4038579, 4038580, 4038581, 4038582, 4038583, 4038584, 4038585, 4038586, 4038587, 4038588, 4038589, 4038590, 4038591, 4038592, 4038593, 4038594, 4038595, 4038596, 4038597, 4038598, 4038599, 4038600, 4038601, 4038602, 4038603, 4038604, 4038605, 4038606, 4038607, 4038608, 4038609, 4038610, 4038611, 4038612, 4038613, 4038614, 4038615, 4038616, 4038617, 4038618, 4038619, 4038620, 4038621, 4038622, 4038623, 4038624, 4038625, 4038626, 4038627, 4038628, 4038629, 4038630, 4038631, 4038632, 4038633, 4038634, 4038635, 4038636, 4038637, 4038638, 4038639, 4038640, 4038641, 4038642, 4038643, 4038644, 4038645, 4038646, 4038647, 4038648, 4038649, 4038650, 4038651, 4038652, 4038653, 4038654, 4038655, 4038656, 4038657, 4038658, 4038659, 4038660, 4038661, 4038662, 4038663, 4038664, 4038665, 4038666, 4038667, 4038668, 4038669, 4038670, 4038671, 4038672, 4038673, 4038674, 4038675, 4038676, 4038677, 4038678, 4038679, 4038680, 4038681, 4038682, 4038683, 4038684, 4038685, 4038686, 4038687, 4038688, 4038689, 4038690, 4038691, 4038692, 4038693, 4038694, 4038695, 4038696, 4038697, 4038698, 4038699, 4038700, 4038701, and 4038702.
Cardiac Science Corporation is recalling GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Sc due to Potential for AED to not deliver defibrillation therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for AED to not deliver defibrillation therapy.
Recommended Action
Per FDA guidance
On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who has the AED in their possession. A separate letter is being sent to distributors. The letter advised to install the software upgrades for any units in stock or to forward the software upgrade along with the end user letter enclosed and that the AED information text file generated by the update software must be returned to the firm. The firm will visit the locations of individual national account customers and install the update. OEM partners will be notified and provided the information and update kits to provide to their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026