Device recall
Z-3079-2011: Elekta Synergy The Elekta Synergy System is intended to be used for radiation…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-3079-2011 |
|---|---|
| Recall event | 58874 |
| Product | Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2012 |
| 510(k) numbers | K032996, K051932 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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