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FDA-Device2025-12-24Class IIPROCESSING DEFECT

PATH Madsen Accuscreen DPOAE probe recalled for false hearing test results

PATH
OTHERWI

Stop using affected Madsen Accuscreen DPOAE probes

A speaker component change in certain PATH Madsen Accuscreen DPOAE probes can cause technical distortions that mimic real hearing responses. This may result in incorrect "PASS" outcomes on infant hearing screening tests when a baby should have failed. The issue occurs when high stimulus levels combine with the device's sensitivity settings.

  • Check if your probe serial number matches the recall list (starting with 1008852 through 1009855).
  • If your serial number is listed, stop using the probe immediately and contact PATH for a replacement or repair.
  • Retest any recent infants screened with an affected probe using a different device or probe.
Hazard

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.

Sold states
Domestic: WI. International: Ireland.
Manufactured in
Landsberger Str. 65, Germering, Germany
Products
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2026

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