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Siemens Artis One
No active recall
Manufacturer: Siemens · FDA product code: OWB · Category: Interventional Fluoroscopic X-Ray System
Severity Snapshot
45 total reports2015-04 – 2025-11 date range33.3% physician / facility reported66.7% manufacturer reported1 SKU variants
Failure & Consequence Profiles
Top Failure Modes
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Top Patient Outcomes
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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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