FDAFDA · Food and drugs·Recall number Z-0139-2025
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.
Published October 30, 2024 · Recall initiated: September 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Distributor
- US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
- Lot
- UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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