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Exablate
No active recall
FDA product code: POH · Category: Mr-Guided Focused Ultrasound System
Severity Snapshot
240 total reports2006-02 – 2026-03 date range51.7% physician / facility reported48.3% manufacturer reported4 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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