device recall
savePATH device recall (Cls II)
November 6, 2025updated 5mo ago
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MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) — Reason: 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. — Status: Ongoing
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