GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.
This recall has been terminated (originally issued December 10, 2010).
- Company
- Cardiac Science Corporation
- Recall Initiated
- April 28, 2010
- Posted
- December 10, 2010
- Terminated
- December 8, 2011
- Recall Number
- Z-0589-2011
- Quantity
- 130 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.