Device recall
Z-0316-2025: SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable…
FDA device recall · Class II · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Key facts
| Recall number (Z-number) | Z-0316-2025 |
|---|---|
| Recall event | 95450 |
| Product | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. |
| Product code | JAA |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190373 |
| FEI number | 3002808139 |
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