Device recall
Z-1405-2010: Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1405-2010 |
|---|---|
| Recall event | 55101 |
| Product | Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2010 |
| 510(k) numbers | K051932 |
| 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