Device recall
Z-1794-2012: PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery…
FDA device recall · Class II · Plasma Surgical Inc.
Key facts
| Recall number (Z-number) | Z-1794-2012 |
|---|---|
| Recall event | 61951 |
| Product | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. |
| Product code | GEI |
| Recalling firm | Plasma Surgical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2012 |
| 510(k) numbers | K080197 |
| FEI number | 3004754983 |
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