Power Heart Automatic External Defibrillator, Model 9210 RD
FDA device recall Z-1034-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cardiac Science, Inc.
- Reason for recall
- Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
- Action taken
- A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Distribution
- The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
- Date initiated
- 2004-05-24
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-18
- Location
- Minneapolis, MN
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 (K011901) | Survivalink Corp. | 2002-02-01 |