Shimadzu Medical Systems recalls Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

Recall date

November 20, 2016

Source

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

Recall number

Z-0917-2017

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA

Why it was recalled

Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

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

What was recalled

Shimadzu X-ray TV System, Catalog No. SONIALVISION G4