Device recall
Z-1125-2015: Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating…
FDA device recall · Class III · Alivecor SFO
Key facts
| Recall number (Z-number) | Z-1125-2015 |
|---|---|
| Recall event | 70363 |
| Product | Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays… |
| Product code | DXH |
| Recalling firm | Alivecor SFO |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 18, 2015 |
| 510(k) numbers | K140933 |
| FEI number | 3009715978 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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