Health Canada — Medical Devices · Canada · 2016-08-29 · Type II
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Reported risk: Philips has become aware that while performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as: non uniformity of the image CT number shift, greater than 5 Hounsfield units reduction in gray/white matter differentiation the issue is most severe in the high resolution mode. Philips provides factory reference pediatric scan protocols which are set to high resolution by default. Adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue
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