Home / Recalls / Medical Devices
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin
Recalled October 30, 2024 · FDA recall Z-0139-2025 · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard
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. · FDA Class II
Units
13
Sold at
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Description
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.
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.
Manufacturer(s)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →