Health Canada — Medical Devices · Canada · 2020-08-28 · Type II
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Reported risk: Issue 1: pixel value measurements from the probe, ROI, and region analysis area tools are incorrect on multi-planar reformats (mprs) generated by Merge PACS. Issue 2: black dots may be displayed in a scattered pattern throughout images. Issue 3: software correction to address a incorrect part number reference on the about screen of software version 8.1.2 (References part number for v8.1.1).
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