Health product recall

NGENUITY 3D Visualization System

Last updated

Summary

Product
NGENUITY 3D Visualization System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

NGENUITY 3D Visualization System

Software v1.5

8065000399

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

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Alcon Laboratories Inc.

6201 South Freeway, Fort Worth, Texas, United States, 76134-2099

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75637

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