Device recall
Z-0453-2013: OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The…
FDA device recall · Class II · OmniGuide, Inc.
Key facts
| Recall number (Z-number) | Z-0453-2013 |
|---|---|
| Recall event | 63642 |
| Product | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery… |
| Product code | GEX |
| Recalling firm | OmniGuide, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 16, 2014 |
| 510(k) numbers | K070157 |
| FEI number | 3005350457 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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