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L9000 Light Source
No active recall
FDA product code: GCT · Category: Light Source, Endoscope, Xenon Arc
Severity Snapshot
12 total reports2009-06 – 2015-04 date range0% physician / facility reported100% 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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