Device recall
Z-0163-2020: IMRIS MR/X-ray head fixation device, Model HFD200
FDA device recall · Class II · Deerfield Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-0163-2020 |
|---|---|
| Recall event | 83278 |
| Product | IMRIS MR/X-ray head fixation device, Model HFD200 |
| Product code | HBL |
| Recalling firm | Deerfield Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2020 |
| 510(k) numbers | K113748 |
| FEI number | 3010326005 |
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