FDA Medical Device Recalls (openFDA)
PATH: AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Recall number
- Z-0403-2024
- Recalling firm
- PATH
- Product
- AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Status
- Open, Classified
- Initiated
- 2023-09-26
- Posted
- 2023-11-25
- Terminated
- not on file
- Reason
- Affected lots of product may experience technical distortions to a greater extent than expected.
- 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: qm@pathme.de Phone: +49 (0)89 80076502
- Quantity
- 23 units
- Distribution
- US States: FL, MO, OH, WI
- Lot, serial or model codes
- UDI-DI: 04260223143298; Serial Numbers: 260446-260468
- 510(k) numbers
- ["K133012","K213345"]
- PMA numbers
- not on file
- Product code
- EWO
- Firm FEI
- 3008111228
- Firm city
- Germering
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28