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Health Canada Medical devices

Syngo.Via

Issued May 3, 2022
Issue
Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected: - The original error is not generated in the software but a manual error during the scan. - Incorrect anterior/posterior label can be detected by correlating/comparing with image anatomy. Recall start date: Apr 26, 2022
Hazard description
Software defect
Product
Product name
Syngo.Via
Reference
ID
RA-64141