Device recall
Z-0470-2022: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000…
FDA device recall · Class II · Reflexion Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0470-2022 |
|---|---|
| Recall event | 89212 |
| Product | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" |
| Product code | IYE |
| Recalling firm | Reflexion Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2024 |
| 510(k) numbers | K190978 |
| FEI number | 3011716550 |
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