PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) due to technical distortions that may cause false pass results in hearing tests.
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.
PATH is recalling specific MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probes because a recent component change can cause false pass results in hearing tests. This means the device might incorrectly indicate normal hearing when there is an issue.
The probe's component change causes technical distortions at high sound levels. These distortions can mimic true hearing responses, leading to false pass results where the device shows normal hearing when the patient actually has a hearing issue.
Hearing professionals who use the recalled probes for hearing tests may be affected. Those testing patients with hearing conditions are most at risk of misdiagnosis.
Check for the part number 8-69-41100 on the probe. Serial numbers listed in the recall include 1008852, 1008888, and other numbers starting with 1009.
Look for the serial numbers listed in the recall (e.g., 1008852, 1008888) on the probe.
The probe may give false pass results in hearing tests due to technical distortions from a recent component change.
Check for the part number 8-69-41100 and serial numbers listed in the recall (e.g., 1008852, 1008888).
The recall does not require immediate stop use; affected users should check the serial number and contact PATH if needed.
We’ve drafted a message you can send PATH to request your refund or repair — edit it as you like.
Subject: Recall Z-0940-2026 — PATH PATH Hello, I own a PATH that is covered by recall Z-0940-2026 from PATH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
