Device recall
Z-2100-2017: Mobius3D Product Usage: Mobius3D software is used for quality assurance and…
FDA device recall · Class II · Mobius Medical Systems, LP
Key facts
| Recall number (Z-number) | Z-2100-2017 |
|---|---|
| Recall event | 77177 |
| Product | Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially… |
| Product code | IYE |
| Recalling firm | Mobius Medical Systems, LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2017 |
| 510(k) numbers | K140660 |
| FEI number | 3008610750 |
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