Health Canada — Medical Devices · Canada · 2019-07-19 · Type II
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Reported risk: When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images. This problem may occur after the following sequence of events: Thickness of the patient is 30 cm or more. A fluoro scan is performed. A field of view (FOV) different than the largest FOV is selected. A Cine run is performed. The problem does not occur: If the largest FOV is selected or When performing fluoroscopy or test shot lock in (TSLI) runs.
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