Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Recalled by Shimadzu Medical Systems Due to It was found that the irradiated x-ray may...
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
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Quantity: 12 systems
Why Was This Recalled?
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
Where Was This Sold?
This product was distributed to 37 states: AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OR, PA, RI, SC, SD, TN, TX, WA, WV
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