Device recall
Z-1141-2024: HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM…
FDA device recall · Class II · HeartSine Technologies Ltd
Key facts
| Recall number (Z-number) | Z-1141-2024 |
|---|---|
| Recall event | 93962 |
| Product | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10 |
| Product code | MKJ |
| Recalling firm | HeartSine Technologies Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| 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