FDA recall Z-0139-2025

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Class II · device

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

Status
Ongoing
Initiation date
2024-09-06
Report date
2024-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kyoto, N/A, Japan

Primary source

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