Product Wiki · Recalls · Health Canada — Medical Devices

NGENUITY 3D Visualization System — recall 75637

Health Canada — Medical Devices · Canada · 2024-06-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75637
Date of alert
2024-06-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: Alcon has recently become aware of an anomaly within the NGENUITY™ surgical image guidance functionality available in software version 1.5 (NGENUITY™ ID 8065000399). The anomaly can lead to inaccurate rotational positioning of the image guidance overlay. This anomaly only affects the surgical image guidance functionality within software v1.5. To mitigate the potential for this anomaly, users will be advised to re-perform registration prior to ending the case or if any axis discrepancy is noted. Recall Start Date: May 23, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ngenuity-3d-visualization-syst

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