Sonialvision Safire II recalled over fire hazard

Recall date

January 12, 2018

Source

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

Official notice title

Shimadzu Medical Systems recalls Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for…

Recall number

Z-2060-2018

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.

Why it was recalled

When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.

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

What was recalled

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.