Device recall
Z-0538-2011: Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0538-2011 |
|---|---|
| Recall event | 57111 |
| Product | Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets. |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2010 |
| 510(k) numbers | K030439 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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