Device recall
Z-2082-2019: IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear…
FDA device recall · Class II · Medical Intelligence Medizintechnik Gmbh
Key facts
| Recall number (Z-number) | Z-2082-2019 |
|---|---|
| Recall event | 83358 |
| Product | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. |
| Product code | IYE |
| Recalling firm | Medical Intelligence Medizintechnik Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2023 |
| 510(k) numbers | K072079 |
| FEI number | 3003251135 |
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