Device recall
Z-2917-2011: Automated External Defibrillator (non-wearable). Model number 9200, 9200N…
FDA device recall · Class II · Cardiac Science Corporation
Key facts
| Recall number (Z-number) | Z-2917-2011 |
|---|---|
| Recall event | 59301 |
| Product | Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG… |
| Product code | MKJ |
| Recalling firm | Cardiac Science Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2011 |
| 510(k) numbers | K012197 |
| 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