Health Canada — Medical Devices · Canada · 2019-05-03 · Type II
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Reported risk: The manufacturer was informed by the supplier on 12-Mar-2019 that these sensors' look up calibration files were incorrectly programmed during manufacture. This may result in a reduction of image quality, such as loss of imaging contrast or an increase in image 'noise'. The reduction of image quality may create a possibility for an undiagnosed condition or a mis-diagnosis.
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