Device recall
Z-0004-2019: TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy…
FDA device recall · Class II · Varian Medical Systems
Key facts
| Recall number (Z-number) | Z-0004-2019 |
|---|---|
| Recall event | 81010 |
| Product | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2020 |
| 510(k) numbers | K140528, K143224 |
| FEI number | 3006583922 |
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