Drug recall
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of…
FDA recall event 95406 · Class II · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Key facts
| Event ID | 95406 |
|---|---|
| Recall numbers | Z-0139-2025 |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is… |
| Initiation date | Sep 6, 2024 |
| Report date | Oct 30, 2024 |
| City | Kyoto |
| Country | Japan |
| FEI number | 3002808139 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: