GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.
FDA Recall Z-0589-2011 · Posted 2010-12-10
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Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2010-04-28
Date Terminated2011-12-08
Product Quantity130 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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