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Senti Desktop Flex

PATH medical GmbH · Model 100470-SC · UDI-DI 04260223145285

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510(k) clearances

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Description

Senti Desktop Flex Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally 8. USB data cable AN100418

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.