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Shimadzu Medical Systems recalls Digital Angiography System Bransist safire Generator Model D150GC-40
Recalled March 9, 2022 · FDA recall Z-0654-2022 · 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. · FDA Class II
Units
18
Sold at
U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
Description
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.
Product
Digital Angiography System Bransist safire Generator Model D150GC-40
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →