Device recall
Z-0697-2019: ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe…
FDA device recall · Class II · Swissray Medical AG
Key facts
| Recall number (Z-number) | Z-0697-2019 |
|---|---|
| Recall event | 81749 |
| Product | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in… |
| Product code | MQB |
| Recalling firm | Swissray Medical AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2021 |
| 510(k) numbers | K050718 |
| FEI number | 3002143662 |
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