Recall Z-0991-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science, Inc.
FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143
| Date | Jul 20, 2004 (initiated May 4, 2004) |
| Status | Terminated |
| Reason | Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work. |
| Root cause | Other |
| Action | A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery. |
| Distribution | The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the Middle East and Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031987 | POWERHEART AED G3, MODEL 9300 Cardiac Science, Jul 30, 2003 |