AuDX PRO Device with touchscreen 100098-AUPRecalls & reported problems
PATH medical GmbH · AuDX PRO branded Sentiero · 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.
3 other recalls cover devices cleared under the same FDA submission (K133012); they may or may not involve this specific model.
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
- Sep 26, 2023Class IIOpen, Classified
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0403-2024 · Root cause: Process change control · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133012. One submission often covers many models, so check the product and lot details in each record.
- Z-0402-2024 · Sep 26, 2023 · Open, ClassifiedSENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
- Z-0404-2024 · Sep 26, 2023 · Open, ClassifiedSENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
- Z-0401-2024 · Sep 26, 2023 · Open, ClassifiedSENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
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- 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
- 1077 DPOAE/TEOAE PROBE 8-69-41100PATH 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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