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Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Recalled April 13, 2022 · FDA recall Z-0869-2022 · Shimadzu Medical Systems
Hazard
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. · FDA Class II
Units
12 systems
Sold at
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
Description
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.
Product
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →