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AuDX PRO, mobile medical devices for hearing examinations… recallZ-0403-2024 · Path · initiated Sep 26, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Path or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Affected lots of product may experience technical distortions to a greater extent than expected.

FDA root cause category: Process change control

What the company is doing

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

Recall details

Recall number
Z-0403-2024
Status
Open, Classified
Initiated by the company
Sep 26, 2023
Posted by the FDA
Nov 25, 2023
Recalling firm
Path
Quantity
23 units
Product code
EWO
FDA submissions
K133012, K213345
Distribution
US States: FL, MO, OH, WI

Product description

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

Code information (models, lots, serial numbers)

UDI-DI: 04260223143298; Serial Numbers: 260446-260468

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K133012, K213345 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93275).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page