Device recall
Z-1547-2010: ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software…
FDA device recall · Class II · ZOLL Medical Corporation, World Wide Headquarters
Key facts
| Recall number (Z-number) | Z-1547-2010 |
|---|---|
| Recall event | 55115 |
| Product | ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant… |
| Product code | MKJ |
| Recalling firm | ZOLL Medical Corporation, World Wide Headquarters |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2014 |
| 510(k) numbers | K042007 |
| 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