Device recall
Z-0829-2016: 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3…
FDA device recall · Class II · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-0829-2016 |
|---|---|
| Recall event | 72824 |
| Product | 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2016 |
| 510(k) numbers | K102496 |
| 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