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Evis Lucera Xenon Light Source

No active recall

FDA product code: GCT  · Category: Light Source, Endoscope, Xenon Arc

Severity Snapshot

31 total reports2017-122025-10 date range3.2% physician / facility reported96.8% manufacturer reported1 SKU variants

Reporting Trend

Annual Reporting Volume

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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.

Reported Events

Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.

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