BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Field Safety Notice for Certain GE Responder 2000 Defibrillators, Cardiac Science Corporation

Product group Medical electronics / Electromedical devices
Reference 02006/10

The Cardiac Science Corporation has issued a Field Safety Notice concerning a corrective action of the defibrillator / monitor GE Responder 2000 models 2025653, 2026109 and 2026114 manufactured between July 25, 2008 and October 2, 2009. Potential failures of the interconnection between the circuit board components may result in a delay or inability to deliver therapy. The affected defibrillators will be repaired by their sole distributor GE Healthcare.

Field Safety Notice for Certain GE Responder 2000 Defibrillators, Cardiac Science Corporation , Download_VeroeffentlichtAm_EN PDF, 124KB, File does not meet accessibility standards