Shimadzu Medical Systems recalls Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

Recall date

December 16, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0655-2022

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

Why it was recalled

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40