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Sentiero Screening2

PATH medical GmbH · Model 100250-SC-AuD · UDI-DI 04260223145124

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening2 device with touchscreen AN100098-S2 5. Headphone DD-45 AN100306 6. Probe EP-DP Path long AN100028-US 7. Audio Class4 Advanced Software AN100653 8. DPOAE Quick Software AN100110-Quick 9. FMDPOAE Software AN100536 10. Software label printer AN100414 11. Accessory box Sentiero PT-S AN100902 or Combo AN100261 12. Power supply Sentiero US AN101013+AN100993-USA

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.