Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers):
FDA device recall Z-1424-2010 · posted 2010-04-27 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198 and 2023440. The affected devices were manufactured between October 29, 2003 and February 10, 2009.
- Action taken
- Cardiac Science issued "Urgent - Medical Device Corrective Action" notices dated October 2009. Customers were instructed to identify the affected product and arrange for product replacement with the firm. Where possible, end user information was requested for further follow-up by the firm. For further information, contact Cardiac Science at 1-877-402-4599 or by email at AED155@cardiacscience. com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1171 (US: 569, OUS: 602)
- Distribution
- Worldwide Distribution -- Distributed to the United States, Australia, Belgium, Canada, Chile, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan
- Date initiated
- 2009-10-12
- Date posted
- 2010-04-27
- Date terminated
- 2012-02-13
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWERHEART AED G3, MODEL 9300 (K031987) | Cardiac Science | 2003-07-30 |