Device recall
Z-0589-2011: GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114…
FDA device recall · Class II · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-0589-2011 |
|---|---|
| Recall event | 55977 |
| Product | GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare. |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 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