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Class 2 Device Recall GE Responder 2000 Defibrillator/Monitor |
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Date Initiated by Firm |
April 28, 2010 |
Date Posted |
December 10, 2010 |
Recall Status1 |
Terminated 3 on December 08, 2011 |
Recall Number |
Z-0589-2011 |
Recall Event ID |
55977 |
510(K)Number |
K060934
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Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product |
GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare. |
Code Information |
Serial Numbers: 3201281, 3201806, 3201810, 3201815, 3202223, 3202233, 3202244, 3202248, 3202249, 3202253, 3202255, 3202256, 3202257, 3202260, 3202262, 3202269, 3202271, 3202273, 3202275, 3202280, 3202281, 3202283, 3202284, 3202285, 3202286, 3202287, 3202288, 3202290, 3202291, 3202292, 3202297, 3202299, 3202300, 3202301, 3202303, 3202304, 3202305, 3202306, 3202308, 3202310, 3202311, 3202312, 3202313, 3202315, 3202316, 3202317, 3202319, 3202321, 3202324, 3202327, 3202328, 3202331, 3202332, 3202333, 3202334, 3202336, 3202337, 3202338, 3202339, 3202340, 3202344, 3202347, 3202348, 3202349, 3202350, 3202351, 3202352, 3202354, 3202355, 3202356, 3202357, 3202358, 3202360, 3202361, 3202362, 3202363, 3202364, 3202365, 3202371, 3202377, 3202379, 3202380, 3202381, 3202382, 3202385, 3202386, 3202387, 3202388, 3202389, 3202390, 3202391, 3202392, 3202393, 3202394, 3202395, 3202396, 3202397, 3202398, 3202399, 3202400, 3202401, 3202403, 3202404, 3202405, 3202406, 3202407, 3202408, 3202409, 3202411, 3202412, 3202414, 3202415, 3202416, 3202417, 3202418, 3202419, 3202420, 3202421, 3202422, 3202423, 3202427, 3202429, 3202439, 3202442, 3202443, 3202444, 3202447, 3202448, 3202450, and 3202451. |
Recalling Firm/ Manufacturer |
Cardiac Science Corporation 3303 Monte Villa Pkwy Bothell WA 98021-8969
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For Additional Information Contact |
Michael Matysik 425-402-4026
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Manufacturer Reason for Recall |
Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient's heart rhythm or deliver therapy during a rescue.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Cardiac Science issued a Urgent Medical Device Corrective Action letter dated April 28, 2010 requesting GE Healthcare cease distribution of affected devices and to instruct end users of distributed devices to schedule a service call to have the device corrected. Cardiac will send rework kits no later than June 30, 2010. CSC can be contacted at 44 161 926 0011 to arrange return material authorization and replacement of affected devices. |
Quantity in Commerce |
130 units |
Distribution |
Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE CORPORATION
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