SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followi…

Recall date

September 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0139-2025

FDA classification

Class II

Brand / firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.