Device recall
Z-2834-2018: Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology…
FDA device recall · Class II · LIEBEL-FLARSHEIM COMPANY LLC
Key facts
| Recall number (Z-number) | Z-2834-2018 |
|---|---|
| Recall event | 80174 |
| Product | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive… |
| Product code | MQB |
| Recalling firm | LIEBEL-FLARSHEIM COMPANY LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2023 |
| 510(k) numbers | K121838 |
| FEI number | 3012465398 |
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