PATH recalls SENTIERO Screening2 hearing exam devices with model SOH100098 that may have technical distortions beyond expected levels. Affected units include specific serial ranges.
Affected lots of product may experience technical distortions to a greater extent than expected.
PATH is recalling its SENTIERO Screening2 hearing exam devices (model SOH100098) because some units may show technical distortions more than expected. This could affect hearing test accuracy but does not pose a safety risk to users.
The devices may produce technical distortions in hearing tests that exceed normal expectations. This could lead to less accurate hearing assessments but does not involve physical harm or safety hazards.
Hearing exam professionals using PATH's SENTIERO Screening2 devices with model number SOH100098 are likely affected. Those who use the devices for hearing tests are at the highest risk of inaccurate results.
Check for model number SOH100098 on the device. Affected units have specific serial numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446.
Look for model number SOH100098 on the device to confirm if it's affected.
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 the model and serial numbers.
Check for model number SOH100098 and serial numbers in the ranges: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446.
We’ve drafted a message you can send PATH to request your refund or repair — edit it as you like.
Subject: Recall Z-0402-2024 — PATH PATH Hello, I own a PATH that is covered by recall Z-0402-2024 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.
