Recall Z-1246-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device
| Date | Apr 6, 2010 (initiated Feb 3, 2010) |
| Status | Terminated |
| Reason | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. |
| Root cause | Nonconforming Material/Component |
| Action | The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement |
| Quantity | 5104 |
| Distribution | Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031987 | POWERHEART AED G3, MODEL 9300 Cardiac Science, Jul 30, 2003 |
| K040438 | POWERHEART AED G3A Cardiac Science, Inc., Jul 1, 2004 |
| K040637 | POWERHEART AED G3 PRO Cardiac Science, Inc., Aug 6, 2004 |
| K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) Cardiac Science, Inc., Oct 21, 2005 |
| K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A Cardiac Science Corporation, Sep 10, 2009 |