Recall Z-1033-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science, Inc.
Power Heart AED Automatic External Defibrillator, Model 9200 RD
| Date | Jul 20, 2004 (initiated May 24, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 Survivalink Corp., Feb 1, 2002 |