Device recall
Z-3270-2026: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P…
FDA device recall · Class III · HeartSine Technologies Ltd
Key facts
| Recall number (Z-number) | Z-3270-2026 |
|---|---|
| Recall event | 98483 |
| Product | HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code… |
| Product code | MKJ |
| Recalling firm | HeartSine Technologies Ltd |
| Recall class | Class III |
| 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