FDA Medical Device Recalls (openFDA)
PATH: MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
- Recall number
- Z-0940-2026
- Recalling firm
- PATH
- Product
- MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
- Status
- Open, Classified
- Initiated
- 2025-11-06
- Posted
- 2025-12-18
- Terminated
- not on file
- 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.
- Root cause
- Component change control
- Action
- 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.
- Quantity
- not on file
- Distribution
- Domestic: WI. International: Ireland.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K100661"]
- PMA numbers
- not on file
- Product code
- GWJ
- Firm FEI
- 3008111228
- Firm city
- Germering
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28