Product Wiki · Recalls · Health Canada — Medical Devices

Syngo.Via — recall 64141

Health Canada — Medical Devices · Canada · 2022-05-03 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64141
Date of alert
2022-05-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Radiology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/syngovia-6

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