Device recall
Z-1683-2010: Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114…
FDA device recall · Class II · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-1683-2010 |
|---|---|
| Recall event | 53668 |
| Product | Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2011 |
| 510(k) numbers | K060934 |
| FEI number | 2112020 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database