Recall Z-0766-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
| Date | Mar 4, 2010 (initiated Nov 13, 2009) |
| Status | Terminated |
| Reason | Potential for devices not to deliver therapy |
| Root cause | Process control |
| Action | Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US. |
| Quantity | 3019 |
| Distribution | Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, |
| FDA record | Open on fda.gov |