Z-0139-2025Class II

Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of...

Name: Z-0139-2025 Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of...
Creator: Shimadzu Corporation Medical Systems Division
Published: 2024-09-06
License: https://open.fda.gov/license/

Shimadzu Corporation Medical Systems Division / initiated 2024-09-06 / Open, Classified / root cause: software

FDA source

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began a recall of Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization... on 2024-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0139-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-06
Posted: 2024-10-22
Recalling firm: Shimadzu Corporation Medical Systems Division
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA root cause: Software Design Change
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
Quantity in commerce: 13
Distribution: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Product codes and lots: UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-22

Product code OWB

K123508Class IITriniasShimadzu Corporation / cleared 2014-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)