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

PRODUCT
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

REASON
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..

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

VOLUME OF PRODUCT IN COMMERCE
17

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