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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.

FDA Recall Z-0139-2025 · Posted 2024-10-22

Recalling FirmSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2024-09-06
Product Quantity13

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.

Firm 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

Root Cause

Software Design Change

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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