Cl II Sonialvision Safire II

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


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.


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


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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