Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Trinias unity Recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Due to If digital angiography system is used with a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION directly.
Affected Products
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.
Quantity: 13
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report