Trinias unity — Class II medical device recall Z-0139-2025
Ongoing recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, reported 2024-10-30, distributed nationwide. If digital angiography system is used with a specific catheterization table and the operator directs simultane
| Recall number | Z-0139-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, N/A, Japan |
| Recall initiated | 2024-09-06 |
| Classified | 2024-10-22 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 13 |
| UPC / GTIN / UDI-DI | 04540217049066, 04540217058143, 04540217058327 |
| Serial numbers | 41E58C76B001, 41E58C773001, 41EFC73A5001, 41EFC73A9001, 41EFC73C5001, 41EFC73D9001, 41EFCD77C001, 41EFCD78B001, 41EFCD79A001, 41EFCD79C001, 41EFCD7A6001, 41EFCD7AC001, 41EFCD7D4001 |
| Model numbers | KS-100 |
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.
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 released, the table may continue to move, which the operator can stop by pressing the stop button.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0139-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.