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Sentiero Desktop Diagnostic

PATH medical GmbH · Model 100497-US7 · UDI-DI 04260223141539

EWO GWJ ETY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Sentiero Desktop Diagnostic Set US7 Diagnostic Tymp with Diagnostic OAE Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. 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 12. Accessory box for Tymp probe AN100587 13. Accessory box AB08 AN100734-P 14. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 15. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 16. Test cavity tymp AN100549

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.