Device recall
Z-0973-2011: RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-0973-2011 |
|---|---|
| Recall event | 53198 |
| Product | RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000xp Cardiac Ablation Controllers and Foot Switch are indicated for use in cardiac ablation procedures with standard and… |
| Product code | LPB |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2011 |
| PMA numbers | P920047 |
| FEI number | 3001236349 |
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