Recall Z-0922-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator
| Date | Feb 25, 2009 (initiated Oct 13, 2008) |
| Status | Terminated |
| Reason | Potential for AED to not deliver defibrillation therapy. |
| Root cause | Software design |
| Action | On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who |
| Quantity | 373 devices |
| Distribution | Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) Cardiac Science, Inc., Oct 21, 2005 |