FDA Recall Open, Classified

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.

Recall: Z-0139-2025 · Initiated September 6, 2024

Recall

Recall Number
Z-0139-2025
Event Number
95406
Firm
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
FEI Number
3002808139
Product Code
OWB
Status
Open, Classified
Root Cause
Software Design Change
Initiated
September 6, 2024
Posted
October 22, 2024
Address
1 Kyoto Japan

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.

Reason

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.

Action

On 9/6/24, recall notices were sent to customers who were asked to do the following: 1) Firmware for the system controller requires updating. The work to correct this issue will be performed by your Authorized Service provider. 2) Schedule time with your Distributer to have your system updated. 3) Complete and return the response form to [email protected] Questions can be directed to the firm's National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday

Distribution

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

Quantity

13