FDA Medical devices recall ·
Trinias unity, Digital Angiography System with Catheterization Table… recall
- Recall number
- Z-0139-2025
- Date
- (initiated September 6, 2024)
- Company / brand
- Shimadzu Corporation Medical Systems Division
Nishinokyo Kuwabara -Cho, Kyoto, N/A, Japan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
Distribution
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
States: Illinois Kentucky Massachusetts Ohio South Carolina Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0139-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.