Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press
FDA device recall Z-0771-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- Potential for devices not to deliver therapy
- Action taken
- Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 13654
- Distribution
- Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA,
- Date initiated
- 2009-11-13
- Date posted
- 2010-03-04
- Date terminated
- 2014-10-24
- Location
- Bothell, WA
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 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (K052161) | Cardiac Science, Inc. | 2005-10-21 |
| POWERHEART AED G3A (K040438) | Cardiac Science, Inc. | 2004-07-01 |
| POWERHEART AED G3, MODEL 9300 (K031987) | Cardiac Science | 2003-07-30 |