Device recall
Z-1587-05: Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-1587-05 |
|---|---|
| Recall event | 32687 |
| Product | Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast… |
| Product code | MRM |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2007 |
| PMA numbers | P980049, P980049/S3 |
| FEI number | 2182863 |
At a glance
- None 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