Device recall
Z-0198-2019: J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360…
FDA device recall · Class II · Bovie Medical Corporation
Key facts
| Recall number (Z-number) | Z-0198-2019 |
|---|---|
| Recall event | 80544 |
| Product | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures. |
| Product code | GEI |
| Recalling firm | Bovie Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2019 |
| 510(k) numbers | K152570 |
| FEI number | 3007593903 |
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