Z-0401-2024Class II

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

Name: Z-0401-2024 SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Creator: Path
Published: 2023-09-26
License: https://open.fda.gov/license/

Path / initiated 2023-09-26 / Open, Classified

FDA source

PATH began a recall of SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098 on 2023-09-26. FDA classified it as Class II and gives the reason as "Affected lots of product may experience technical distortions to a greater extent than expected". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0401-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-26
Posted: 2023-11-25
Recalling firm: Path
Product: SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Product code: EWO Audiometer
Reason for recall: Affected lots of product may experience technical distortions to a greater extent than expected.
FDA root cause: Process change control
Action: An URGENT: MEDICAL DEVICE RECALL SENTIERO notification letter dated 9/26/23 was sent to customers. Actions to be taken by the User: The technical distortions can influence the specified performance of the device when performing diagnostic DPOAEs at high stimuli. Therefore, PATH MEDICAL chose to voluntarily recall affected products for correction. 1. Immediately identify any affected devices at your location and quarantine them. 2. Please return your affected device(s) to your local distributor or PATH MEDICAL directly (Shipping Address: Landsberger Str. 65, 82110 Germering, Germany) to have your PCB replaced. Upon request, return labels can be provided. 3. If the device(s) have been further distributed to other accounts, please forward this notice to them to inform them of the recall. 4. Report any adverse events to FDA MedWatch: Use the MedWatch Online Reporting Form or call 800-332-1088. Re-Screening of patients screened with a device subject to the recall is not necessary, as regular DPAOE screening would not be done at stimuli as high as they would be affected by the issue. Furthermore, DPOAE-based hearing screening always consists of measurements at multiple frequencies. Therefore, false positive DPOAE detections at a single frequency, which are already considered unlikely, would not necessarily falsify the overall screening result (e.g., pass criterion 3 out of 4). Please be aware that your local competent authority may have been informed of this recall, if required by law. Thank you for your cooperation. In case there are additional questions, please contact us under: Mail: [email protected] Phone: +49 (0)89 80076502
Quantity in commerce: 15 units
Distribution: US States: FL, MO, OH, WI
Product codes and lots: UDI-DI: 04260223142437; Serial Numbers: 201015-201029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-24
Z-0402-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-24
Z-0403-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-24
Z-0404-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-24

Product code EWO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)