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Health Canada Medical devices

NGENUITY 3D Visualization System

Issued June 7, 2024
Issue
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
Hazard description
Performance
Product
Product name
NGENUITY 3D Visualization System
Reference
ID
RA-75637