medical Class II Updated 2018-10-31

Shimadzu Medical Systems Usa Com recalls TRINIAS Digital Angiographic System intended to be used for

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Affected States: LA
Lot/Code Info: Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001
View official government recall

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