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Sentiero Advanced

PATH medical GmbH · Model 100340-US1 · UDI-DI 04260223141591

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Sentiero Advanced ABR US1 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 8. Binaural ABR Diagnostics SW, time saving up to 40%. Broadband Chirp and click Stimuli to be used with Headphone or Ear Probe or Oto insert phone. AN100424 9. Software label printer AN100414 10. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 11. Power pack Sentiero Advanced AN101016 + 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.