Device recall
Z-3178-2011: STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-3178-2011 |
|---|---|
| Recall event | 59331 |
| Product | STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert… |
| Product code | LPB |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2012 |
| PMA numbers | P990071 |
| FEI number | 3003113629 |
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