Device recall
Z-2174-2025: HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine…
FDA device recall · Class II · HeartSine Technologies Ltd
Key facts
| Recall number (Z-number) | Z-2174-2025 |
|---|---|
| Recall event | 96890 |
| Product | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator) |
| Product code | MKJ |
| Recalling firm | HeartSine Technologies Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160008 |
| FEI number | 3004123209 |
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