Device recall
Z-3120-2026: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes…
FDA device recall · Class II · HeartSine Technologies Ltd
Key facts
| Recall number (Z-number) | Z-3120-2026 |
|---|---|
| Recall event | 99568 |
| Product | 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: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2… |
| 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