Official recall record

NGENUITY 3D Visualization System

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

Issuing authority: Health Canada — Medical Devices
Published: 2024-06-07
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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