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Sentiero Desktop Diagnostic

PATH medical GmbH · Model 100497-ED · UDI-DI 04260223145292

EWOGWJETY Prescription
1
510(k) clearances
63
Adverse events
5
Recalls
65
Facilities

Description

Sentiero Desktop Easy Diag Set Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Headphone DD-45 AN100306 4. Probe EP-TY long AN100188-US 5. FW Screening Tymp class 1 AN100561 6. Mira PC Patient Management Software 7. Software label printer AN100414 8. Accessory box for Tymp probe AN100587 9. Accessory box AB08 AN100734-P 10. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 11. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 12. Test cavity tymp AN100549

Recalls

DateFirmReason
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16Cardinal Health, IncGSI 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.