Reported Jun 20, 2018 · Terminated
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for…
Shimadzu Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- Sonialvision Safire II, Model #:
- DAR-8000f Product UsageThis 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
- Lot codes and dates
Serial #: 0161G681010261G653030261G657020261G682043M72BFB210013M72BFB2A0013M72BFC2A0013M72BFC2C0013M72BFB320013M72BFB320063M72BFB330033M72BFC330013M72BFC340013M72BFB350053M72BFC370023M72BFC420013M72BFB46002
- Amount recalled
- 17
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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