MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Reported: December 24, 2025 Initiated: November 6, 2025 #Z-0940-2026
Product Description
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Reason for Recall
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.
Details
- Recalling Firm
- PATH
- Distribution
- Domestic: WI. International: Ireland.
- Location
- Germering
Frequently Asked Questions
What product was recalled? ▼
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100). Recalled by PATH.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0940-2026.
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