Device recall
Z-0317-2025: The FLUOROspeed is intended to be used as a universal diagnostic imaging system…
FDA device recall · Class II · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Key facts
| Recall number (Z-number) | Z-0317-2025 |
|---|---|
| Recall event | 95450 |
| Product | The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on… |
| Product code | JAA |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191877 |
| 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