# FDA recall Z-0139-2025

> **SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION** · Class II · device recall initiated 2024-09-06.

## 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.

## Distribution

US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.

## Key facts

- **Recall number:** Z-0139-2025
- **Recalling firm:** SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-06
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kyoto, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2025

## Citation

> AI Analytics. FDA recall Z-0139-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0139-2025. Source: US FDA. Licensed CC0.

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