Device recall
Z-2348-2008: Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being…
FDA device recall · Class II · Acacia Engineered Products LLC
Key facts
| Recall number (Z-number) | Z-2348-2008 |
|---|---|
| Recall event | 48990 |
| Product | Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems. |
| Product code | LXV |
| Recalling firm | Acacia Engineered Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2010 |
| FEI number | 3006503914 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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