Device recall
Z-2064-2011: Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software…
FDA device recall · Class I · Defibtech, LLC
Key facts
| Recall number (Z-number) | Z-2064-2011 |
|---|---|
| Recall event | 58160 |
| Product | Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The… |
| Product code | MKJ |
| Recalling firm | Defibtech, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 30, 2021 |
| 510(k) numbers | K013896, K033896 |
| FEI number | 3003521780 |
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