Device recall
Z-0581-2007: Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR…
FDA device recall · Class I · Defibtech, LLC
Key facts
| Recall number (Z-number) | Z-0581-2007 |
|---|---|
| Recall event | 37394 |
| Product | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier) |
| Product code | MKJ |
| Recalling firm | Defibtech, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 9, 2021 |
| FEI number | 3003521780 |
At a glance
- None 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