Device recall
Z-0841-04: Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio…
FDA device recall · Class II · Gyrus Medical, Inc
Key facts
| Recall number (Z-number) | Z-0841-04 |
|---|---|
| Recall event | 27883 |
| Product | Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. |
| Product code | GEI |
| Recalling firm | Gyrus Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2006 |
| FEI number | 3011050570 |
At a glance
- None 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