Z-0922-2009

GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science...

Name: Z-0922-2009 GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science...
Creator: Cardiac Science Corporation
Published: 2008-10-13
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2008-10-13 / Terminated / root cause: software

FDA source

Cardiac Science Corporation began a recall of GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator on 2008-10-13. The reason FDA records is "Potential for AED to not deliver defibrillation therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0922-2009
Status: Terminated
Initiated: 2008-10-13
Posted: 2009-02-25
Terminated: 2011-12-08
Recalling firm: ZOLL Medical Corporation
Product: GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential for AED to not deliver defibrillation therapy.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 373 devices
Distribution: Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, UK, and Ukraine.
Product codes and lots: 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.

Product code MKJ

K052161Class IIIPowerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)Cardiac Science, Inc. / cleared 2005-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)