Device recall
Z-0195-2009: GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog)…
FDA device recall · Class II · Cardinal Health, Inc
Key facts
| Recall number (Z-number) | Z-0195-2009 |
|---|---|
| Recall event | 49546 |
| Product | GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds… |
| Product code | EWO |
| Recalling firm | Cardinal Health, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2012 |
| 510(k) numbers | K011135 |
| FEI number | 3010611950 |
At a glance
- 1–9 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