Path MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Source: FDA | Recall date: 12/24/2025

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Affected product: MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Brand: path

Hazard: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.

Official identifiers

FDA recall number: Z-0940-2026
FDA event number: 97894

Open FDA Enforcement Record Back to Home Search FDA recall records

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