Device recall
Z-2376-2015: PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker…
FDA device recall · Class II · BIOTRONIK, Inc.
Key facts
| Recall number (Z-number) | Z-2376-2015 |
|---|---|
| Recall event | 71658 |
| Product | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. |
| Product code | rce |
| Recalling firm | BIOTRONIK, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2015 |
| PMA numbers | P950037, P950037S148 |
| FEI number | 1028232 |
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