Device recall
Z-1057-2012: Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the…
FDA device recall · Class I · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-1057-2012 |
|---|---|
| Recall event | 60992 |
| Product | Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. The Powerheart AED G3 is indicated for emergency treatment of… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 27, 2013 |
| 510(k) numbers | K031987 |
| 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