FDA Device recall Z-0139-2025
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components:…
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components:… by Shimadzu Medical Systems Division, citing 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 dir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0139-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-06 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Shimadzu Medical Systems Division |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFC…UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0139-2025%22
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