Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactur
FDA device recall Z-0400-05 · posted 2005-01-15 · Terminated
Recall details
- Recalling firm
- Cardiac Science, Inc.
- Reason for recall
- AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
- Action taken
- Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 193
- Distribution
- Throughout the United States, Canada and Europe.
- Date initiated
- 2004-11-12
- Date posted
- 2005-01-15
- Date terminated
- 2006-06-25
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWERHEART AED G3 PRO (K040637) | Cardiac Science, Inc. | 2004-08-06 |