Recall – X-Ray System

Company: Shimadzu Medical Systems.
Date of Enforcement Report 6/20/2018
Class II:

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. Recall Number: Z-2060-2018

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..

IShimadzu Medical Systems, Torrence, CA on 1/12/2018. Voluntary: Firm Initiated recall is ongoing.


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