Device recall
Z-0141-2027: Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number…
FDA device recall · Class II · Cadwell Industries Inc
Key facts
| Recall number (Z-number) | Z-0141-2027 |
|---|---|
| Recall event | 99774 |
| Product | Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator… |
| Product code | GWF |
| Recalling firm | Cadwell Industries Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162199 |
| FEI number | 3020018 |
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