PATH is recalling the MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe due to a component change in the probe's speaker that may cause technical distortions. These distortions can mimic real hearing responses, leading the device to display a 'PASS' result when it should not. This issue affects 76 specific probes with Part Number 8-69-41100. Facilities using these probes should stop use immediately and contact the manufacturer or their distributor for a replacement or technical correction.
The defect can cause a patient to receive a false 'PASS' result during a hearing screening, even if hearing loss is present. This could lead to a delayed diagnosis of hearing impairment, potentially postponing critical medical treatment or developmental support for the patient.
Affected units follow a component change in the DPOAE probe (speaker replacement).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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