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Shimadzu Medical Systems Usa Com recalls TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal an
Recalled October 31, 2018 · FDA recall Z-0197-2019 · Shimadzu Medical Systems Usa Com
Hazard
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel. · FDA Class II
Units
1
Sold at
Domestic: LA
Description
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
Product
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer(s)
Shimadzu Medical Systems Usa Com
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →