MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) (PATH Landsberger Str. 65 Germering Germany) – following a component change in the d... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Brand
PATH Landsberger Str. 65 Germering Germany
Lot Codes / Batch Numbers
Part Number: 8-69-41100, UDI-DI: 04260223141355, Serial Numbers: 1008852, 1008888, 1008916, 1008925, 1008935, 1008945, 1008951, 1008957, 1008960, 1008962, 1008966, 1008967, 1008987, 1008990, 1009054, 1009065, 1009066, 1009131, 1009137, 1009138, 1009139, 1009145, 1009148, 1009155, 1009159, 1009161, 1009169, 1009184, 1009188, 1009191, 1009305, 1009315, 1009316, 1009319, 1009321, 1009322, 1009325, 1009328, 1009343, 1009352, 1009356, 1009357, 1009359, 1009366, 1009372, 1009375, 1009376, 1009386, 1009388, 1009390, 1009396, 1009399, 1009400, 1009404, 1009411, 1009415, 1009419, 1009426, 1009427, 1009432, 1009439, 1009442, 1009454, 1009456, 1009460, 1009463, 1009464, 1009468, 1009475, 1009481, 1009488, 1009494, 1009495, 1009497, 1009848, 1009855.
Products Sold
Part Number: 8-69-41100; UDI-DI: 04260223141355; Serial Numbers: 1008852, 1008888, 1008916, 1008925, 1008935, 1008945, 1008951, 1008957, 1008960, 1008962, 1008966, 1008967, 1008987, 1008990, 1009054, 1009065, 1009066, 1009131, 1009137, 1009138, 1009139, 1009145, 1009148, 1009155, 1009159, 1009161, 1009169, 1009184, 1009188, 1009191, 1009305, 1009315, 1009316, 1009319, 1009321, 1009322, 1009325, 1009328, 1009343, 1009352, 1009356, 1009357, 1009359, 1009366, 1009372, 1009375, 1009376, 1009386, 1009388, 1009390, 1009396, 1009399, 1009400, 1009404, 1009411, 1009415, 1009419, 1009426, 1009427, 1009432, 1009439, 1009442, 1009454, 1009456, 1009460, 1009463, 1009464, 1009468, 1009475, 1009481, 1009488, 1009494, 1009495, 1009497, 1009848, 1009855.
PATH Landsberger Str. 65 Germering Germany is recalling MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) due to Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 6, 2025 URGENT: MEDICAL DEVICE Field Corrective Action letters were sent to their two distributors. Actions to be taken: - Users will be asked to confirm the DPOAE protocol in use. - Verify the DPOAE Protocol used is not affected by the issue (DP1, DP2, DP3, DP4, DP17, DP18, DP19, DP20, DP21). - If any other protocol is used, please replace it by using AccuLink Software. Follow instructions in IFU to do so. - Remove all affected protocols (DP5-DP16) using AccuLink Software. Follow instructions in IFU to do so. - Complete and return the attached form to confirm these steps were followed. - The expected lifetime of the probes is two years from date of manufacture. Please put the products out of use, once this is reached.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
WI
Page updated: Jan 10, 2026