FDA-Device2022-03-09Class II
Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu Medical Systems
Hazard
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Sold states
U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
Affected count
18
Manufactured in
20101 S Vermont Ave, Torrance, CA, United States
Products
Digital Angiography System Bransist safire Generator Model D150GC-40
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2022Don't want to check this manually?
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