Sentiero 100098-SRecalls & reported problems

PATH medical GmbH · Sentiero Screening Device with Touchscreen · Class 2

All models of Sentiero (3)

Data updated Oct 16, 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 16, 2026.

Recalls naming this device

Sep 26, 2023Open, Classified
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0404-2024 · 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-0403-2024 · Sep 26, 2023 · Open, Classified
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Z-0402-2024 · Sep 26, 2023 · Open, Classified
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Z-0401-2024 · Sep 26, 2023 · Open, Classified
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

Device details

UDI-DI	`04260223142475`
Brand	Sentiero
Model	100098-S
Company	PATH medical GmbH
Product code	EWO · Audiometer
Class	Class 2
FDA submission	K133012
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Evoked-potential audiometer

An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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