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Health Canada Medical devices

SYNGO.PLAZA

Issued November 19, 2021
Issue
MRI images with certain values in the Dicom tags rescale slope (0028,1053) and rescale intercept (0028, 1052) can show wrong statistical values 'min/max' (maximum and minimum grayscale value in the ROI) and 'Mean/STD D' (mean value and standard deviation of the grayscale values) in the ROI, which can lead to an inconsistent, conflicting holistic view on the patient Recall start date: 2021-09-30
Hazard description
Inaccurate test or measurement results
Product
Product name
SYNGO.PLAZA
Reference
ID
RA-63612