Alcon Research LLC recalls Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will…
Read the official notice →- Date
- 2024-07-24
- Country
- United States
- Brand
- Alcon Research
- Product
- Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, CA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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