Device recall
Z-3265-2011: Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency…
FDA device recall · Class II · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-3265-2011 |
|---|---|
| Recall event | 59303 |
| Product | Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2014 |
| 510(k) numbers | K031987, K040438, K052161 |
| FEI number | 2112020 |
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