Recall Z-0940-2026 ยท GWJ Stimulator, Auditory, Evoked Response
PATH
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
| Date | Dec 18, 2025 (initiated Nov 6, 2025) |
| Status | Open, Classified |
| 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 foll |
| Distribution | Domestic: WI. International: Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100661 | EARPROBE Path Medical GmbH, Jul 1, 2010 |