Device evidence

device-recall:cfres:167416

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 number

Z-0197-2019

Evidence summary

Product code: OWB
Recall status: Terminated
Event initiated: June 15, 2018
Root cause: Software design
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0197-2019