Recall Z-0589-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.
| Date | Dec 10, 2010 (initiated Apr 28, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 130 units |
| Distribution | Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060934 | MODIFICATION TO POWERHEART ECD Cardiac Science Corporation, May 15, 2006 |