Device recall
Z-1034-2026: Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog…
FDA device recall · Class II · IMRIS Imaging Inc
Key facts
| Recall number (Z-number) | Z-1034-2026 |
|---|---|
| Recall event | 98132 |
| Product | Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the… |
| Product code | HBL |
| Recalling firm | IMRIS Imaging Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K103493 |
| 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