Device recall
Z-0139-2025: Trinias unity, Digital Angiography System with Catheterization Table, Model…
FDA device recall · Class II · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Key facts
| Recall number (Z-number) | Z-0139-2025 |
|---|---|
| Recall event | 95406 |
| Product | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component. |
| Product code | OWB |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K123508 |
| 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