Shimadzu Medical Systems Usa Com recalls TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal a…

Recall date

June 15, 2018

Source

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

Recall number

Z-0197-2019

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems Usa Com

Sold / distributed

Domestic: LA

Why it was recalled

Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.

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

What was recalled

TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.