FDA-Device2022-04-13Class II
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
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.
Sold states
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
Affected count
25 systems
Manufactured in
20101 S Vermont Ave, Torrance, CA, United States
Products
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2022Don't want to check this manually?
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