Recall Z-0940-2026— PATH
Class II · Ongoing
Class II FDA medical device recall by PATH, initiated 2025-11-06. It names one FDA 510(k) clearance: K100661. Product: 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..
- Recalling firm
- PATH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-06
- Firm location
- Germering, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.