Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 1077 DPOAE/TEOAE PROBE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall 1077 DPOAE/TEOAE PROBEsee related information
Date Initiated by FirmNovember 06, 2025
Date PostedDecember 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0940-2026
Recall Event ID 97894
510(K)NumberK100661 
Product Classification Stimulator, auditory, evoked response - Product Code GWJ
ProductMADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Code Information 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.
FEI Number 3008111228
Recalling Firm/
Manufacturer		 PATH
Landsberger Str. 65
Germering Germany
For Additional Information ContactDr. Johann Oswald
+498980076502
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component change control
ActionOn 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.
DistributionDomestic: WI. International: Ireland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWJ
-
-