FDAJune 15, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
shimadzu medical systems usa comshimadzushimadzu medical
UPCs
04540217049080
Recall history
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