Product Wiki · Recalls · Health Canada — Medical Devices

EOSedge imaging device (2020-12-29) — recall 62004

Health Canada — Medical Devices · Canada · 2021-01-15 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62004
Date of alert
2021-01-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: When the operator performs a biplanar acquisition (frontal and lateral simultaneously) with Eosedge system, with patient orientation different from AP (antero-posterior) and when user manually adjusts at least one reference plane position at the 'review' step, resulting images are not properly resized. 2D measurements made on these images may be incorrect.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/eosedge-imaging-device-2020-12

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