Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142
FDA device recall Z-0990-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cardiac Science, Inc.
- Reason for recall
- Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- 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.
- Date initiated
- 2004-05-04
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-18
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWERHEART AED G3, MODEL 9300 (K031987) | Cardiac Science | 2003-07-30 |