Device recall
Z-2315-2009: ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical…
FDA device recall · Class II · ZOLL Medical Corporation, World Wide Headquarters
Key facts
| Recall number (Z-number) | Z-2315-2009 |
|---|---|
| Recall event | 53162 |
| Product | ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. |
| Product code | MKJ |
| Recalling firm | ZOLL Medical Corporation, World Wide Headquarters |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2012 |
| 510(k) numbers | K060559 |
| FEI number | 1220908 |
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