Medical Device Recall: 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
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · September 6, 2024
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.
Product Description
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.
Distribution
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
States Affected
NATIONWIDE
Quantity Affected
13
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0139-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.