NGENUITY 3D Visualization System recall in Canada: Performance issue
In plain language
This recall involves the NGENUITY 3D Visualization System, Software v1.5, sold in Canada. It's being recalled because of a performance anomaly that can lead to inaccurate rotational positioning of image guidance. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
- Re-perform registration prior to ending a case or if any axis discrepancy is noted.
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Affected products
NGENUITY 3D Visualization System Software v1.5
Lot: 8065000399
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 8065000399
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Contact the manufacturer if you require additional information. Re-perform registration prior to ending a case or if any axis discrepancy is noted.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on June 7, 2024.
Is the Alcon Laboratories Inc. brand affected by this recall?
Yes, Alcon Laboratories Inc. products are affected by this recall. This recall involves the NGENUITY 3D Visualization System, Software v1.5, sold in Canada. It's being recalled because of a performance anomaly that can lead to inaccurate rotational positioning of image guidance. Healthcare professionals should contact the manufacturer for more information.