Device recall
Z-0771-2010: Cardiac Science Powerheart 9390E automated external defibrillator. This…
FDA device recall · Class I · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-0771-2010 |
|---|---|
| Recall event | 53827 |
| Product | Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 24, 2014 |
| 510(k) numbers | K031987, K040438, K052161 |
| FEI number | 2112020 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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