Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sonialvision Safire II Recalled by Shimadzu Medical Systems Due to When selecting serial radiography with a pulse rate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shimadzu Medical Systems directly.
Affected Products
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.
Quantity: 17
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shimadzu Medical Systems
Shimadzu Medical Systems has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report