Device recall
Z-0652-05: Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and…
FDA device recall · Class II · Compumedics Usa, Ltd
Key facts
| Recall number (Z-number) | Z-0652-05 |
|---|---|
| Recall event | 31197 |
| Product | Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia |
| Product code | GWQ |
| Recalling firm | Compumedics Usa, Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2007 |
| 510(k) numbers | K000068 |
| FEI number | 3002716534 |
At a glance
- 1–9 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