Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator
This recall has been terminated (originally issued February 25, 2009).
- Company
- Cardiac Science Corporation
- Recall Initiated
- October 13, 2008
- Posted
- February 25, 2009
- Terminated
- December 8, 2011
- Recall Number
- Z-0921-2009
- Quantity
- 1,064 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for AED to not deliver defibrillation therapy.
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.
Lot / Code Info
Serial numbers: 4000787, 4001399, 4001409, 4006332, 4006693, 4010635, 4022160, 4022185, 4022187, 4022196, 4033017, 4033018, 4033019, 4033020, 4033021, 4033022, 4033023, 4033024, 4033025, 4033026, 4033027, 4033028, 4033029, 4033030, 4033031, 4033032, 4033033, 4033034, 4033035, 4033036, 4033037, 4033038, 4033039, 4033040, 4033041, 4033042, 4033043, 4033044, 4033045, 4033046, 4033047, 4033048, 4033049, 4033050, 4033051, 4033052, 4033053, 4033054, 4033055, 4033056, 4033057, 4033058, 4033059, 4033060, 4033061, 4033062, 4033063, 4033064, 4033065, 4033066, 4033067, 4033068, 4033069, 4033070, 4033071, 4033072, 4033073, 4033074, 4033075, 4033076, 4033077, 4033078, 4033079, 4033080, 4033081, 4033082, 4033083, 4033084, 4033085, 4033086, 4033087, 4035338, 4035339, 4035340, 4035341, 4035342, 4035343, 4035344, 4035345, 4035346, 4035347, 4035348, 4035349, 4035350, 4035351, 4035352, 4035353, 4035354, 4035355, 4035356, 4035357, 4035358, 4035359, 4035360, 4035361, 4035362, 4035363, 4035364, 4035365, 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4111554, 4111555, 4111556, 4111557, 4111558, 4111559, 4111560, 4111561, 4111562, 4111563, 4111564, 4111565, 4111566, 4111567, 4111568, 4111569, 4111570, 4111571, 4111572, 4111573, 4111574, 4111575, 4111576, 4111577, 4111578, 4111579, 4111580, 4111581, 4111582, 4111583, 4111584, 4111585, 4111586, 4111587, 4111588, 4111589, 4111590, 4111591, 4111592, 4111593, 4111594, 4111595, 4111596, 4111597, 4111598, 4111599, 4111600, 4111601, 4111602, 4111603, 4111604, 92532-0000522, 92532-0000526, 92532-0000583, 92532-0000610, 92532-0000622, 92532-0000635, 92532-0000680, 92532-0000689, 92532-0000702, 92532-0000723, 92532-0000916, 92532-0000945, 92532-0000954, 92532-0001085, 92532-0001104, and 92532-0001193.
Root Cause
Software design
Action Taken
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.