Class 2 Device Recall Cardio Vive

• Date Initiated by Firm: October 13, 2008
• Date Posted: February 25, 2009
• Recall Status: Terminated on December 08, 2011
• Recall Number: Z-0921-2009
• Recall Event ID: 50064
• 510(K)Number: K040438
• Product Classification: Automated External Defibrillator - Product Code MKJ
• Product: Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator
• Code Information: 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, 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4111552, 4111553, 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.
• Recalling Firm/ Manufacturer: Cardiac Science Corporation; 3303 Monte Villa Pkwy; Bothell WA 98021-8969
• For Additional Information Contact: Bev Magrane; 425-402-2000
• Manufacturer Reason for Recall: Potential for AED to not deliver defibrillation therapy.
• FDA Determined 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: 1,064 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE, INC.