Device recall
Z-1046-05: HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
FDA device recall · Class II · Heartsine Technologies Inc
Key facts
| Recall number (Z-number) | Z-1046-05 |
|---|---|
| Recall event | 31445 |
| Product | HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003. |
| Product code | MKJ |
| Recalling firm | Heartsine Technologies Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K023854 |
| FEI number | 3004018643 |
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