Device recall
Z-0138-2014: Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0138-2014 |
|---|---|
| Recall event | 65782 |
| Product | Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. |
| Product code | HAW |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2014 |
| 510(k) numbers | K011255 |
| 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