PATH: Device Recall
Recall #Z-0940-2026 · 11/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0940-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- PATH
- Status
- Ongoing
- Date Initiated
- 11/06/2025
- Location
- Germering, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Product Description
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Distribution Pattern
Domestic: WI. International: Ireland.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.