PATH is recalling 67 units of its SENTIERO, SENTIERO Screening2, AuDX PRO, and SENTIERO SCREENING mobile hearing examination devices. These medical devices may experience technical distortions that exceed expected levels, which can interfere with the accuracy of hearing examinations. The affected products include various models and were distributed in Florida, Missouri, Ohio, and Wisconsin.
Excessive technical distortions in these hearing screening devices can lead to inaccurate test results or errors during patient evaluations. While no injuries have been reported, inaccurate diagnostic data could lead to incorrect clinical decisions or delayed treatment for hearing conditions.
Manufacturer instructions
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.
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Sources: FDA iRES · Raw API Response
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