Device recall
Z-1297-2019: Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance…
FDA device recall · Class II · Elekta Limited
Key facts
| Recall number (Z-number) | Z-1297-2019 |
|---|---|
| Recall event | 82537 |
| Product | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined… |
| Product code | IYE |
| Recalling firm | Elekta Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2023 |
| 510(k) numbers | K182076 |
| FEI number | 3002806900 |
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