1077 DPOAE/TEOAE PROBE 8-69-41100Recalls & reported problems
PATH medical GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 6, 2025Class IIOpen, Classified
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.
Z-0940-2026 · Root cause: Component change control · Recall details · FDA record ↗
Other Stimulator, Auditory, Evoked Response devices
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone 2 Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- GN Otometrics A/S ICS Chartr EP 200 Insert 2 Ch, US OnlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- AuDX PRO Device with touchscreen 100098-AUPPATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- ALGO Newborn Hearing Screener ALGO 5Natus Medical Incorporated · Stimulator, Auditory, Evoked Response3 reports
- NIM-Eclipse® NCCPUMedtronic Xomed, Inc. · STIMULATOR, AUDITORY, EVOKED RESPONSE2 reports
- GN Otometrics A/S MADSEN AccuScreenNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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