FDAJanuary 12, 2018device
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 populat...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
shimadzu medical systemsshimadzushimadzu medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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