PATH SOH100098 Hearing Screening Device: Technical Distortion Risk

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Recalling firmPATHLandsberger Str. 65 · Germering, N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

PATH is recalling mobile hearing screening devices with model number SOH100098 because some units may show technical distortions beyond normal expectations. This could lead to inaccurate hearing test results.

Why it’s dangerous

The device may produce technical distortions that affect hearing test accuracy more than expected. This could lead to incorrect hearing results if the device is used without proper calibration.

Who’s affected

Hearing professionals using PATH's mobile hearing screening devices are most likely affected. The risk is low as the issue relates to potential technical distortions rather than safety hazards.

How to tell if you have this one

Check for model number SOH100098 and part number 100098-S on the device. Affected units have serial number 280117.

Brand
PATH
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model number SOH100098, part number 100098-S, and serial number 280117 to confirm if your device is affected.

✎ GovInfoNow

Questions people ask

Is this device dangerous to use?

No, the recall is for potential technical distortions that could affect hearing test accuracy, not a safety hazard.

What should I do if I have this device?

Check the device details to see if it matches the affected model and serial number. If affected, contact PATH for further instructions.

How can I tell if my device is affected?

Look for model number SOH100098, part number 100098-S, and serial number 280117 on the device.

Take action

Contact PATH

We’ve drafted a message you can send PATH to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0404-2024 — PATH PATH

Hello,

I own a PATH that is covered by recall Z-0404-2024 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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Where this comes from

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.

Official source: FDA Recall #Z-0404-2024 (September 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0404-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

PATH recalls SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

Lower-risk recall