Device recall
Z-2060-2018: Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic…
FDA device recall · Class II · Shimadzu Medical Systems
Key facts
| Recall number (Z-number) | Z-2060-2018 |
|---|---|
| Recall event | 80067 |
| Product | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient… |
| Product code | IZI |
| Recalling firm | Shimadzu Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2022 |
| 510(k) numbers | K052500 |
| FEI number | 1000125362 |
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