FDA-Device2024-03-20Class II

Shimadzu, Trinias, Digital Angiography System

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Sold states
US Nationwide distribution in the states of OH.
Affected count
1
Manufactured in
Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, Japan
Products
Shimadzu, Trinias, Digital Angiography System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2024

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