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Ngenuity 3d visualization system
Official notice
7 Jun 2024
Last checked
7 Jun 2024
An official Health Canada notice concerns Ngenuity 3d visualization system. 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 Published 2024-06-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75637
Official notice
2024-06-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Alcon Laboratories, Ngenuity 3d Visualization System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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