Device recall
Z-0460-2019: RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage…
FDA device recall · Class II · Virtual Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-0460-2019 |
|---|---|
| Recall event | 81444 |
| Product | RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the… |
| Product code | MQB |
| Recalling firm | Virtual Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| 510(k) numbers | K101517 |
| FEI number | 1000649926 |
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