Device recall
Z-0442-2024: ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0442-2024 |
|---|---|
| Recall event | 93264 |
| Product | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K210500 |
| 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