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Shimadzu Medical Systems recalls Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used
Recalled June 20, 2018 · FDA recall Z-2060-2018 · Shimadzu Medical Systems
Hazard
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. · FDA Class II
Units
17
Sold at
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Description
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.
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.
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →