Device recall
Z-0620-2013: Companion External Battery, Part Number: 293001-001 The Companion External…
FDA device recall · Class II · SynCardia Systems Inc.
Key facts
| Recall number (Z-number) | Z-0620-2013 |
|---|---|
| Recall event | 63915 |
| Product | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac… |
| Product code | DSZ |
| Recalling firm | SynCardia Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2013 |
| PMA numbers | P030011 |
| FEI number | 3003761017 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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