Device recall
Z-1438-2013: adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes…
FDA device recall · Class II · TZ Medical Inc.
Key facts
| Recall number (Z-number) | Z-1438-2013 |
|---|---|
| Recall event | 65120 |
| Product | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and… |
| Product code | DRO |
| Recalling firm | TZ Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2013 |
| 510(k) numbers | K983196 |
| FEI number | 1000127185 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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