Shimadzu X-ray High Voltage Generator recalled over fire hazard

Recall date

November 20, 2016

Source

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

Official notice title

Shimadzu Medical Systems recalls Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray…

Recall number

Z-0918-2017

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.

Why it was recalled

Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the 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 High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.