Senti Set 2

PATH medical GmbH · Model 100450 · UDI-DI 04260223142963

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Senti Audiometry (Class 3) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Headphone HDA-280 AN100117 7. Bone conductor B71 with patient response button AN100214 8. Power supply AN100083 9. USB data cable AN100089

Recalls

Date	Firm	Reason
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16	Cardinal Health, Inc	GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.