PATH recalls AuDX PRO hearing exam devices (model SOH100098) due to potential technical distortions affecting hearing tests. Affected units have specific serial numbers and part numbers.
Affected lots of product may experience technical distortions to a greater extent than expected.
PATH is recalling its AuDX PRO mobile hearing exam devices because some units may cause more technical distortions than expected during hearing tests. This could lead to inaccurate hearing results if the device is used without proper calibration.
The device may produce more technical distortions than expected during hearing tests. This could result in inaccurate hearing results if the device is not properly calibrated. However, the hazard does not involve physical injury or safety risks.
Hearing professionals using PATH AuDX PRO devices for hearing examinations are most likely affected. The risk is low as the issue relates to technical distortions rather than safety hazards.
Check for model number SOH100098 and part number 100098-AUP on the device. Affected units have serial numbers from 260446 to 260468.
Verify the model number (SOH100098) and part number (100098-AUP) on the device.
No, the recall does not require stopping use. The issue is about potential technical distortions, not safety risks.
The recall does not specify a remedy, so no action is needed beyond checking device details.
Check for model number SOH100098, part number 100098-AUP, and serial numbers 260446-260468.
We’ve drafted a message you can send PATH to request your refund or repair — edit it as you like.
Subject: Recall Z-0403-2024 — PATH PATH Hello, I own a PATH that is covered by recall Z-0403-2024 from PATH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
