Device recall
Z-0641-05: Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003…
FDA device recall · Class I · Heartsine Technologies Inc
Key facts
| Recall number (Z-number) | Z-0641-05 |
|---|---|
| Recall event | 31212 |
| Product | Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected). |
| Product code | MKJ |
| Recalling firm | Heartsine Technologies Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 8, 2011 |
| FEI number | 3004018643 |
At a glance
- None 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