Device recall
Z-0124-2013: HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to…
FDA device recall · Class I · Heartsine Technologies, Limited
Key facts
| Recall number (Z-number) | Z-0124-2013 |
|---|---|
| Recall event | 63139 |
| Product | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not… |
| Product code | MKJ |
| Recalling firm | Heartsine Technologies, Limited |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 10, 2015 |
| 510(k) numbers | K041067, K052465 |
| FEI number | 3004123209 |
At a glance
- 1–9 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