Device recall
Z-0799-2012: NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License…
FDA device recall · Class I · CareFusion 209 Inc.
Key facts
| Recall number (Z-number) | Z-0799-2012 |
|---|---|
| Recall event | 60223 |
| Product | NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain… |
| Product code | GYC |
| Recalling firm | CareFusion 209 Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 21, 2012 |
| 510(k) numbers | K072964 |
| 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