Device recall
Z-1422-2009: EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 /…
FDA device recall · Class III · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-1422-2009 |
|---|---|
| Recall event | 51681 |
| Product | EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures. |
| Product code | JOQ |
| Recalling firm | St. Jude Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 20, 2010 |
| 510(k) numbers | K040207, K994011 |
| FEI number | 2126673 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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