Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin
Summary
The FDA issued a Class II for Trinias unity, Digital Angiography System with Catheterization Table, Model: KS- by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. 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 .
Details
Source
Device Recall
External ID
Z-0139-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
Quantity Affected: 13
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-06
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION have FDA actions?
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0139-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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