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Health Canada Medical devices

SYNGO IMAGING - SYSTEM IUK

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: 2021-09-29
Hazard description
Inaccurate test or measurement results
Product
Product name
SYNGO IMAGING - SYSTEM IUK
Reference
ID
RA-63613